PATIENT INFORMATION

COPING STRATEGIES

CRYOPRESERVATION INFORMATION

CRYOPRESERVATION PERMISSION

THE REALITY OF BLASTOCYST TRANSFER

FINANCIAL INFORMATION

IVF OVERVIEW

PRE-IVF SEMEN ANALYSIS

IVF INFORM CONSENT

IVF SHARED RISK PROGRAMME

MICRO-INSEMINATION PATIENT INFORMATION

MICRO-INSEMINATION PERMISSION (Informed Consent)

PATIENT INSTRUCTIONS

PSYCHOLOGICAL CONSENT

SUCCESS RATES

THE EMOTIONAL EFFECTS OF INFERTILITY (on the couple relationship)

COPING STRATEGIES

How you can survive your fertility treatments

Part of the problem of "coping" with infertility is that we all have the notion that we should do it gracefully, with a minimum of tears and hysterics.

Who told us that was coping? Who made the rules that said don't cry too much; don't show your feelings too much; don't let your feelings affect your work or relationships at all?

The next important question is: Why do we accept these rules? What's wrong with having our feelings? Grief is a natural process. Infertility is an on-going stressful crisis where we repeatedly experience grief. In short, it's a terrible experience we wouldn't wish on our worst enemies.

People can't experience fertility problems without being affected emotionally unless their feelings are so well protected that they're not in touch with them. Don't put yourself down because you get upset. Learn now that your reaction is normal. You've chosen the coping style that you know best. But, you can make things better. Start by identifying the positives about your coping style. Focus on how well you're doing. Give yourself credit for how well you've succeeded. For instance, many women put themselves down for feeling the need to talk to people a lot. Well, using support systems is an excellent way of dealing with stressful life experiences. Most people don't know how to deal with such intense pain. So give yourself positive self-talk about how good you are at reaching out for help. If you can't find the positives in what you are doing, ask a friend or your partner. There's always a way. Infertility often creates or exacerbates marital conflict. Find time to talk about it and decide if it's conflict within your relationship or if it's created by your infertility experience. Talk about the ways you've solved problems before and see if any of these work. If not, ask friends what they've done or seek out counselling. It is normal for marriages to have problems during this time. If you can survive this crisis together, you can handle just about anything.

Friends and family members often seem insensitive and say or do things out of their ignorance, discomfort or feelings of helplessness. Educate them when you are strong enough. Tell them how you feel. By explaining your feelings and letting people know how to help, you will often get what you need. "I really appreciate your wanting to offer advice, but, right now I have enough advice and what I need most is someone to listen and try to understand," is an expression of what many infertility patients feel but cannot communicate. Don't wait until you are in crisis or you'll tend to talk yourself out of dealing with them and they'll never learn what you need from them.

Medical caregivers have feelings about your infertility also and may react in a number of ways which may or may not feel good to you. Give them feedback about what feels good and what doesn't so they learn, and so your anger and resentment don't build. You'll be helping yourself right now and contributing to other infertile couples in the future.

Co-workers and employers may also react in hurtful ways or not understand your need for time off, your emotional ups and downs. Educate them when you can. Find supports in your workplace. Imagine you have another illness that doesn't have the social stigma of infertility and give yourself as much permission as you would in that situation to use your time as medically recommended and expect others to honour this as well.

Remember what you've done in the past to make it through difficult times and see if it can work for you now as well. Find time to have fun, read books, do nice things for yourself, buy things, meet new people, take exciting classes. Learn to do something you've always been afraid to try. Develop a sense of humour about the infertility experience (this actually can be done on your better days). Use this time to develop deeper and more intimate relationships with your partner and others you care for. Go for counselling, join a support group at RESOLVE, get online or do anything else your heart desires. You deserve it!

HUMAN EMBRYO CRYOPRESERVATION

CURRENT STATUS
The first pregnancy from a frozen/thawed human embryo was reported in 1983, and a birth from this source occurred the following year. Of 71,826 cases of Assisted Reproductive Technology (ART)* in 1997, about 14% of cases (10,181) used frozen/thawed embryos. Overall, more than half of frozen embryos survived after thawing. In 1997, live birth rates per thaw cycle were 16.8% versus 29.7% from fresh embryo transfer. Since some embryos do not survive the thaw and, therefore are not transferred, the live birth rate per thawed embryo transfer was somewhat higher at 18.6%.

CRYOPRESERVATION OF HUMAN EMBRYOS
Egg retrieval under ultrasound guidance and subsequent fertilization and embryo culture are carried out according to our current procedures. If there happens to be a surplus of embryos following selection for fresh transfer (usually between one to four embryos are transferred to the uterus), then embryos of sufficient quality may be considered for cryostorage. While embryos can be frozen at any preimplantation stage between one-cell (one day old) to the blastocyst stage (5-6 days old), in an attempt to minimize the freezing of excessive numbers of "spare" embryos and to help pre-select the most potentially viable embryos, we generally choose to cryopreserve only at the blastocyst stage. In certain cases where all embryos need to be frozen without a fresh transfer (e.g., when a woman may be at risk from ovarian hyperstimulation that might be complicated by pregnancy), we generally freeze all embryos the day after egg collection at the one-cell stage.

Techniques of controlled-rate freezing are utilized that slowly cool embryos in cryoprotectant fluid ("anti-freeze" solution) from body temperature down to -196° C, at which temperature they are stored in containers of liquid nitrogen called dewars. The embryos are actually contained within special indelibly labelled plastic vials, or straws, that are sealed prior to freezing. Once frozen, they are placed inside labelled tubes attached to aluminium canes and stored in numbered canisters within the liquid nitrogen dewar. Site and label designations are stored in three separate file systems to avoid confusion and misidentification of cryopreserved embryos. When it comes time to thaw the embryos, all available identifiers of the stored specimen must match and be confirmed before thawing commences. The embryos are thawed out in at room temperature, which takes about one to two minutes. However, the most critical element of the thaw procedure is not the timing but the careful dilution of the cryoprotectant fluid to return the embryo to its favoured culture medium. This permits resumed growth and development in vitro. Once this is done, the embryo is assessed for cryodamage to determine if it is suitable for transfer. Experience has shown that if the embryo survives 50% or more intact, it is worthwhile to replace it. Embryos can accommodate such levels of cellular damage and still establish healthy pregnancies. All thawed embryos routinely undergo assisted hatching prior to transfer. The zona pellucida, which surrounds the embryo, has been shown to suffer a certain amount of hardening during cryopreservation. This can be overcome by artificially making an opening in the outer embryo shell.

Varying strategies may be applied according to how many and which embryos are thawed prior to transfer. It should be noted that not every couple undergoing IVF will need to worry about embryo freezing/thawing, since not every couple will have sufficiently large number of "surplus" or non-transferred embryos available for freezing. Indeed, most couples have only one or two embryos frozen, so that all are thawed and any surviving are replaced. In the event that there are more than two or three embryos frozen, thawing is usually undertaken until two to three healthy appearing embryos are recovered. In some cases, this may mean that all the cryopreserved embryos are thawed, in others just two or three. There always remains a possibility that there may be no embryo survival after thaw occurs, and no transfer is possible. If many early embryos are frozen, it is possible to thaw all of them and culture them for several days to allow selection of the best for transfer. When too many embryos are available for transfer in this circumstance, then extra embryos of sufficient quality may be refrozen for later use. This course of action has produced healthy offspring, proving the efficacy of double freezing of embryos.

During a medication-prepared frozen/thawed embryo transfer cycle as a patient, you will follow a treatment schedule using Synarel or Lupron, oestrogen (pills, lozenge or patch) and progesterone (lozenge and/or suppository) in order to achieve appropriate endometrium (uterine wall lining) for embryo transfer. Following embryo transfer, oestrogen and progesterone will be administered daily until the 7 th to 8 th week of pregnancy or until a negative pregnancy test.

CONSIDERATIONS AND RISKS
The Ethics Committee of the American Society of Reproductive Medicine (ASRM) has published guidelines for ethical consideration of human embryo cryopreservation. Possible advantages of cryopreservation of embryos suggested by the Committee include:

Reduction of the risk of triplets or quadruplets by cryopreservation of embryos exceeding an optimal number for transfer to an individual patient
Possibly increasing pregnancy rates by replacing thawed embryos during spontaneous ovulatory cycles or cycles in which the oestrogen and progesterone hormone levels do not exceed that which occurs naturally
Possibly decreasing the number of stimulated ovary drug treatment cycles needed for the attainment of pregnancy

The primary concern with the use of cryopreservation techniques is the possible loss of embryos to cryoinjury, meaning some healthy embryos may not survive the stress of freezing & thawing. The exact number of embryos lost to cryoinjury varies, but it is very likely that freezing will cause loss of some embryos, perhaps as many as 25-50% of those cryostored. One interpretation of this is that cryopreservation may even act as a "selection gate" for the more viable embryos, though this has never been proven.

Another concern with cryopreservation is the potential risk of birth defects in children produced from frozen/thawed embryos. In the domestic animal industry, large-scale freezing and transfer of embryos has not resulted in increased birth defects. Studies to date on those human offspring arising from thawed embryos have not shown any significant increase in abnormalities when compared to pregnancy outcomes in the rest of the population.

To optimise the likelihood of successful embryo cryopreservation at GIH, the mechanical processes of human embryo cryopreservation will be strictly controlled to minimize the chances of technical failure. A back-up freezing system is always available to decrease the risk of interruption in the freezing process, as well as generator back-up power in the event of a power outage. Individual embryos are placed in permanently labelled storage containers and identified according to origin, developmental stage, and date frozen. Permanent records are kept at GIH Reproductive Specialists for each individual's embryos. Liquid nitrogen dewars are connected to alarm systems to monitor the liquid nitrogen levels and prevents premature thawing. However, even with all these safeguards, the possibility of technical failure leading to loss of stored embryos following natural disaster cannot be totally and completely eliminated.

PERIOD OF CRYOSTORAGE
The disposition of any frozen embryos that are not transferred must be arranged in writing before cryopreservation (see Cryopreservation Consent Form). In the event that a successful pregnancy is established following a fresh or subsequent embryo thaw cycle, it will be at the discretion of the couple as to whether the remaining frozen embryos should continue to be cryostored, or appropriately discarded or donated. This may include the option to donate the embryos for research or to other infertile couples for transfer.

Cryopreservation records, along with all records of medical care and procedures will be maintained in the strictest confidence at GIH Reproductive Specialists.

INFORMED CONSENT

CRYOPRESERVATION OF FERTILIZED EGGS AND/OR EMBRYOS

We, _____________( referred to herein as "Patient") and ______________ (referred to herein as Spouse/Partner), have elected to use embryo cryopreservation (freezing) as a component of our in vitro fertilization (IVF) therapy at Gulu Independent Hospital (referred to herein as "GIH").

BACKGROUND
In the course of an IVF treatment cycle, more viable embryos may be produced than are desired for embryo transfer in that same cycle. If so, these "excess" embryos can be preserved by freezing and storing for future use. In addition, there are conditions under which the physician managing your treatment will recommend that all embryos be frozen and that no embryo replacement be performed during your IVF treatment cycle. One such reason for this recommendation would be if the patient is at high risk for hyperstimulation syndrome at the time of your oocyte retrieval. Hyperstimulation syndrome is exacerbated by pregnancy and is easier to manage if the patient is not pregnant. In this situation, all viable embryos will be frozen and the replacement of thawed embryos will be performed only after the patient has recovered from the hyperstimulation.

Embryos may be frozen anywhere from 5 to 7 days of culture at the blastocyst stage. If the patient and spouse/partner consent to cryopreservation, the stage at which any embryos are frozen will be determined by laboratory personnel in conjunction with the physician managing your treatment.

The embryos will be stored in the frozen condition for up to five years. When the patient and spouse/partner request their use and the physician responsible for your care determines that appropriate conditions exist for transfer of the embryos into the patient's uterus, some or all of the embryos will be thawed. Each embryo will be examined to determine whether it is viable, and if so, the transfer into the patient's uterus will occur.

The pregnancy success rate with frozen embryos transferred into the human uterus is approximately the same as with non-frozen embryos. However, some embryos do not survive the freezing process. Potential benefits of embryo freezing are an increased opportunity of achieving a pregnancy without undergoing multiple egg retrievals, a reduced risk of a multiple pregnancy (twins or more) by reducing the number of embryos transferred during the IVF treatment cycle, and better management of complications associated with the IVF treatment cycle such as hyperstimulation, as described above.

RISKS AND LIMITATIONS
1. Establishing an IVF pregnancy using frozen thawed embryos cannot be guaranteed for any woman;

2. Some or all embryos may not survive freezing and thawing;

3. Additional expenses are associated with the use of embryo freezing;

4. Embryo freezing has been successfully used in animals with no known adverse results. There is, however, relatively limited experience with human embryos. Although no birth defects have been reported from the limited number of births from frozen human embryos, the risks associated with human embryo freezing, thawing and transfer are not well established at present;

5. Failure of storage containers can result in the loss of liquid nitrogen and damage or destroy all of the embryos. Embryos are stored in industry-standard semen storage tanks that are monitored daily for liquid nitrogen level and maintained at greater than 75% of their capacity. The tanks are monitored by an alarm system that will signal laboratory personnel should liquid nitrogen levels become dangerously low. Even so, there is the potential that a tank might fail due to a spontaneous loss of vacuum or rupture of the vessel. Disasters such as fires and storms, as well as criminal acts, could damage the building housing the tanks and/or the tanks themselves. Any such event could result in the loss of the specimens.

6. The Patient and Spouse/Partner must agree to and accept future disposal of any remaining unused frozen embryos. Options are described below.

We understand and agree that frozen fertilized eggs and/or embryos will be stored by GIH for a maximum of five years. The storage fee for the first year of embryo storage is included in the initial cryopreservation fee. We also understand that at the beginning of year two and for each subsequent storage year we will be required to pay the storage fees for that year in advance. Such fees are non-refundable in whole or in part. We agree to pay any storage fees as such fees become due.

We agree to immediately update GIH should our address change and agree that our failure to maintain a current address with GIH and/or the inability of GIH to collect annual storage fees will signify our desire to terminate storage of frozen embryos. In such an event, or following the fifth anniversary of cryopreservation, whichever comes first, the frozen embryos will be disposed of in the manner we have indicated in the following section.

DISPOSAL OF EXCESS FROZEN EMBRYOS
Should the yearly fee for storage of your frozen embryo(s) remain unpaid for a period of 6 months after the first invoice is forwarded to our address, as it is listed in our clinical records at GIH, GIH can conclude that we are no longer interested in storing these specimen(s) and GIH may dispose of all of our frozen embryos in the manner we have indicated below. In addition, GIH will dispose of the frozen embryos in the manner we have indicated below if we provide written notification of our desire for the embryos to be discarded.

In the event that either of the above mentioned situations occur, we hereby instruct and authorize GIH to dispose of any frozen embryos as follows (Patient and Spouse/Partner must both initial the same choice):

_____ ______ Thaw and dispose of the frozen embryos in any manner deemed appropriate by GIH.

_____ ______ Donate the frozen embryos to GIH to offer the embryos for anonymous adoption by another couple. It is understood that if we select this option we waive any right and relinquish any claim to the donated embryos or any pregnancy or offspring that might result from them. We agree that any recipient receiving embryos which we have donated to GIH may regard the donated embryos and any offspring resulting there from as her/their own children. If no adoptive couple is found, GIH, at its discretion, is authorized to thaw and dispose of the embryos in any manner deemed appropriate by GIH.

_____ _____ Donate the embryos to GIH for use in research projects permitted under the policies of Gulu Independent Hospitals' policies and applicable legal requirements.

In the case of one of the circumstances listed below, we instruct GIH to conduct disposition of any and all remaining frozen embryos based on our current wishes. Our wishes regarding each of the following situations are indicated by our initials. (Patient and Spouse/Partner must both initial the same choice):

· Patient's Death
_____ ______ Disposition of embryos to be determined by Spouse/Partner.
_____ ______ Disposal of the embryos in any manner deemed appropriate by GIH.
· Spouse/Partner's Death
_____ ______ Disposition of embryos to be determined by Patient.
_____ ______ Disposal of the embryos in any manner deemed appropriate by GIH.
· Divorce (if not addressed in the divorce settlement)
_____ ______ Disposition of embryos to be determined by Patient
_____ ______ Disposition of embryos to be determined by Spouse.
_____ ______ Disposal of the embryos in any manner deemed appropriate by GIH.

COMPREHENSION OF CONSENT AGREEMENT
We have read and understand this document and all additional information provided to us. We have discussed this document and additional information with Dr. Kaplan, Dr. Perloe or Dr. Sills, who has provided us ample opportunity to ask any questions regarding IVF therapy and cryopreservation and who has answered these questions to our satisfaction. We acknowledge that no guarantee or assurance has been made as to the results that may be obtained. We further acknowledge that this document is by no means a complete record of our conversations with Gulu Independent Hospitals' physicians and staff, and we are satisfied that we have been sufficiently advised and informed to make this decision.

CONSENT
We, understand and accept the conditions, risks and limitations of embryo cryopreservation. We therefore voluntarily consent to the use of embryo cryopreservation to preserve the excess embryos resulting from our IVF therapy for potential future use. We are eighteen (18) years of age or older.

RELEASE
We agree to absolve, release, indemnify, protect and hold harmless Dr. -------Independent Hospital, its officers, directors, agents and employees from any and all liability for any adverse outcome, however remote, resulting from the cryopreservation and storage of our fertilized eggs and/or embryos, including, but not limited to, the loss or destruction of our fertilized eggs and/or embryos, and/or the birth of a physically or mentally deficient child. Additionally, we release, discharge and acquit harmless, GIH its officers, directors, agents and employees from any and all liability in connection with any subsequent disputes between Patient and Spouse/Partner regarding the control of any frozen fertilized eggs or embryos, or the custody and/or support of any children ultimately born as a result of this procedure.

__________________________________________________________________

Patient

Date

__________________________________________________________________

Partner

Date

__________________________________________________________________

Financial Counsellor	Date

FEWER RISKS, NEW HOPE: THE REALITY OF BLASTOCYST TRANSFERS

INTRODUCTION
The first thing that usually comes to mind when people hear the term, "infertility treatment," is the risk of multiple births. This worry has been fuelled by the recent highly publicized multiple births in Iowa and Texas. While such cases are rare, the incidence of triplets or higher-order births as a result of assisted reproductive technology is of great concern to all infertility practitioners and patients. For countless couples, deciding against treatment may mean abandoning their dream of having a child.

But what if there was a way to reduce or even eliminate the risk of multiples? Not only would that help more couples become parents, it would also decrease maternal and neonatal risks. That possibility is becoming a reality, thanks to a new technique known as blastocyst transfer. With blastocyst transfer, fewer embryos are transferred while maintaining and even increasing pregnancy rates. This technique virtually eliminates the risk of triplets or greater.

THE SIGNIFICANCE OF BLASTOCYST TRANSFER
In a typical non-blastocyst in vitro fertilization (IVF) cycle, a woman's eggs are retrieved and fertilized. If all goes well, the embryos are transferred into the uterus three days later. Due to the fact that it is difficult to predict on day three which embryos are more likely to produce a pregnancy, four or more embryos are frequently transferred in hopes that at least one will result in a live birth. Until now, this has been a reasonable approach in order to achieve acceptable pregnancy rates.

The downside is that sometimes all the embryos become ongoing pregnancies and the result is high-order multiple gestations (triplets or greater). In such pregnancies, there are considerable medical risks as well as financial and emotional considerations. So the couple is faced with the agonizing decision of whether to opt for selective reduction (the removal of one or more embryos) or to continue with a risky pregnancy. Although everyone agrees that every possible safeguard should be in place to avoid such unfortunate situations, the distressing reality is that multiple pregnancies sometimes do occur.

However, with blastocyst transfer, only two or three embryos are transferred, practically eliminating the possibility of triplets or greater. And the same pregnancy rates are achieved as would be expected when four or more embryos are transferred on day three. Some centres report achieving even better pregnancy rates with blastocysts. Implantation rates of 48-50% and pregnancy rates of up to 66.3% have been reported in patients who responded well to gonadotropins.

WHAT IS A BLASTOCYST?
A blastocyst is a highly developed embryo that has divided many times to a point where it is nearly ready to implant on the walls of the uterus. A blastocyst has come a long way from its beginning as a single cell.

During maturation, an embryo rests inside a protective shell called a zona pellucida. You can think of this protective shell as being much like a chicken egg. But, unlike chicken eggs, human embryos do not remain inside a shell. Instead, the embryo hatches (breaks out of the shell) on the fifth or sixth day so it can attach to the uterine wall (implantation). Just prior to hatching, an embryo becomes a blastocyst.

Embryos developing to the critical blastocyst stage have a much greater chance of implanting successfully and resulting in an ongoing pregnancy. That is because these embryos have passed an important test. During the first few days, the embryo relies on the mother's egg for all its nutrients. However, in order to 15 survive past day three or four, the embryo must activate its own genes. Not all embryos are successful. In fact, only about one-third of the embryos become blastocysts. Yet these embryos are more highly-developed, healthier, and stronger, and have a higher rate of implantation when compared to day three embryos. Due to the higher probability of survival, we transfer fewer back into the uterus.

GETTING TO DAY FIVE
For many years, infertility practitioners have known that day three transfers were too early when compared to what is physiologically normal. In naturally conceived pregnancies, a day three embryo resides in the fallopian tube, not in the uterus. The embryo does not even reach the uterus until the fifth or sixth day. Yet traditional IVF has always transferred on day three because, up until now, we have not been able to delay the transfer to day five. Previous laboratory culture media could only sustain an embryo's growth for three days. Now we have the ability to develop an embryo to the blastocyst (day five) stage.

What has made the difference is the recognition that the nutritional requirements of the embryo change as it develops. That knowledge led to the development of different laboratory culture media for the embryo's specific developmental stages. This so-called "sequential media" attempts to reproduce the natural environment of the maternal reproductive tract. The nutrients are designed to meet the requirements of the rapidly developing embryo and have led to the development of blastocysts with better viability and higher implantation rates.

REDEFINING DEVELOPMENTAL POTENTIAL
The ability to develop embryos to the blastocyst stage allows clinicians to have greater certainty about which embryos are more likely to implant. Interestingly, no correlation has been found between what is traditionally considered a "good embryo" on day three and a "good blastocyst" on day five. Previously, Dr. Tucker reported a "significant disparity between the two stages in embryo viability estimates," meaning that even the best embryologists cannot tell which day three embryos have the potential to develop into a blastocyst.

While the quality of blastocysts is determined by examining morphology and development, it is important to point out that blastocyst grading standards are currently under development. Although the ability for the embryo to grow into a blastocyst is a milestone, other factors also play a role in its further development. In the near future, we believe we will be able to accurately predict which blastocysts are destined for success. When that happens, single blastocyst transfers will be considered the norm, and IVF will likely be considered the first-line infertility treatment.

WHO DOES IT HELP?
Determining who is a good candidate for blastocyst transfer is another rapidly evolving area. As more information becomes available and our knowledge base grows, guidelines based on actual clinical experience will be developed. Until then, we can offer some preliminary observations.

In general, blastocyst transfer is more advantageous for patients who develop a number of eggs and embryos. A significant correlation has been reported between the number of eggs and the number of blastocysts developed, as well as the number of day three embryos and the number of blastocysts developed. Other candidates for blastocyst transfer include those who would not consider foetal reduction or those in whom delivering multiple pregnancies would be of particular concern. Blastocyst transfer is probably not advantageous for patients who develop few eggs or embryos.

A side benefit of a blastocyst transfer is the fact that the ability to generate a blastocyst provides important information about the likelihood of pregnancy. In general, pregnancy rates are higher in those whose embryos grow to the blastocyst stage. Conversely, pregnancy rates are lower in those whose embryos do not develop into blastocysts.

MATERNAL AGE AND BLASTOCYST DEVELOPMENT
Does maternal age have any bearing on the production of blastocysts? Although some studies have shown advanced maternal age to be a factor in blastocyst production, Schoolcraft found "no correlation between percentage of blastocyst formation and increasing maternal age" in a population of women who responded well to gonadotropins. However, implantation rates and pregnancy rates in this study decreased with maternal age, with women over 40 faring the worst.

WHAT HAPPENS WHEN EMBRYOS DO NOT BECOME BLASTOCYSTS?
Because only a few embryos develop to the blastocyst stage, it is possible to have no embryos survive to day five to transfer. This is especially true if the cycle begins with only a few fertilized eggs. When no embryos survive to become blastocysts, it is a tremendous disappointment. The looming question then becomes, "Would the embryos that did not survive to become blastocysts have implanted if transferred at day three?" Unfortunately, we simply do not have enough clinical data at this time to answer that question. In our opinion, pregnancy would have been unlikely in that situation. But since that outcome is not a certainty, day three transfers may still be a reasonable option for some patients.

GENETIC TESTING AND BLASTOCYSTS
Another benefit of blastocyst transfer is the ability to perform biopsies on a more highly-developed embryo in order to test for genetic diseases. In the future, immunofluorescent testing techniques will allow practitioners to remove a few cells from the blastocyst, stain them, and examine them under the microscope to detect any genetic anomalies. While that type of testing is not currently available on a day-to-day basis, we believe it will be considered routine within the next two to five years.

FROZEN BLASTOCYST CYCLES
Blastocysts tend to have a very good survival rate after cryopreservation (freezing). Menezo and his colleagues have reported that "the recovery after thawing is equivalent, if not superior to, that of thawing of earlier embryonic stages."

Because blastocysts are superior to earlier stage embryos in terms of development, they are easier to freeze, store, and thaw. Additionally, because blastocysts have higher implantation rates, it is possible for a couple to go through IVF once and have enough blastocysts for the current cycle as well as any future cycles.

THE FUTURE
We are just beginning to understand the implications of blastocyst transfer for both practitioners and patients. ,We believe infertility treatment centres will soon be able to reliably grow blastocysts and accurately assess which embryos are destined to implant and develop into an ongoing pregnancy. When that happens, the transfer of a single blastocyst will become the norm. And today's risk of high-order multiples will become a memory. The future holds much hope, much promise, and considerably fewer risks.

FINANCIAL INFORMATION

Currently, most health insurance plans do not cover assisted reproductive technologies. Although insurance coverage may be available for pre-IVF evaluation, most plans that exclude IVF treatments will exclude visits, procedures, testing and laboratory studies in preparation for an IVF treatment cycle. However, plans vary widely and you should check your individual policy or call your insurance company to determine if, and to what extent these procedures are covered. If you do not have coverage, submitting charges to your insurance company for reimbursement may constitute fraud.

Verification of your coverage and a pre-determination letter are required before we agree to bill your insurance carrier for IVF-related procedures. If you believe your health plan provides coverage for IVF, and we are contracted with your plan to provide IVF and other assisted reproductive technologies, we will request a predetermination of benefits on your behalf. It may take up to 30 days to receive a response from the insurance company. Prior to our receipt of coverage information, payments for IVF- related procedures and lab studies will be required of you. When we receive acknowledgement of benefits, we will file claims for services incurred and make any appropriate refunds to you.

NO INSURANCE COVERAGE FOR IVF

____

We understand that if we are covered by an insurance plan that does not cover assisted reproductive technology or we do not have insurance, a pre-paid IVF fee of -------- will be required. This payment must be received by GIH no later than the date that the first IVF medication is initiated. The pre-paid IVF fee will cover the following medical care to be provided during our IVF cycle:

Ultrasounds and office visits during ovulation induction
Oestrogen, progesterone and LH blood tests during treatment
Physician, anesthesia & embryology professional fees
Laboratory and medical supplies associated with retrieval and transfer
Cryopreservation of embryos and two years of storage

Payment for charges not covered by the pre-paid IVF fee will be expected at the time that services are rendered. These services include:

New patient evaluation	Pre-cycle office visits
Pre-cycle ultrasounds	Medication and drug supplies
Pre-cycle laboratory testing	Counselling or teaching visits
Pregnancy testing	Pregnancy ultrasounds
Embryo biopsy

____

We understand that refunds will not be provided after I/we have started my ovulation induction treatment. If my cycle is cancelled and retrieval is not performed, GIH (at its sole discretion) will make an itemized accounting of charges and determine whether a refund is due. If a refund is due, the balance amount may be applied to the next ART cycle. Understand that laboratory expenses may be incurred even when my cycle is cancelled. GIH will refund $500 if embryo transfer is not performed.

____

We understand that we may not request a refund after starting ovulation induction treatment. However, if the cycle is cancelled due to poor response or other reasons determined by the physician and retrieval is not performed, GIH will make an itemized accounting of charges and determine whether a refund is due. If a refund is due, the balance amount may be applied to the next IVF cycle. If the egg retrieval is performed but the embryo transfer does not take place, GIH will refund $500.

ESTIMATED TOTAL COSTS FOR IVF

Pre-cycle Testing & Counselling

Medications for Ovulation Stimulation

*IVF Fee - Cycle Monitoring, Retrieval, Transfer & Cryopreservation*	~
*Estimated total for IVF cycle*	~

LIMITED INSURANCE COVERAGE FOR IVF

____

We understand that we may wish to submit charges to our insurance company for consideration of reimbursement and that we may submit copies of the daily encounter form. The insurance company may directly reimburse us for any covered procedures. If a predetermination of benefits indicates that insurance coverage for IVF is not available, any subsequent insurance payments received by Georgia Reproductive Specialists will be returned to the insurance company.

WHEN INSURANCE COVERAGE HAS BEEN DOCUMENTED

Georgia Reproductive Specialists has received a letter from your insurance company indicating that coverage for the proposed assisted reproductive technology procedures are presently covered under the terms of your current medical policy. Benefits are provided only if the coverage is still in effect at the time the services are rendered.

? Co-pay of $_______ per office visit is required.

? Co-insurance of _______% of the health plan UCR is required.

Annual deductible of $_______ is required of which $_______ has been met to date.

Your insurance plan has a maximum infertility lifetime benefit of $_______ of which $_______ has been paid to date. Your insurance plan has an out-of-pocket maximum of $_______.

____

We understand that we am responsible for payment of any deductible amounts or charges that are not covered by our plan. These payments are due at the time of service.

____

We understand that in order to be successful, IVF requires timely access to laboratory studies performed by techniques that may not be available though the laboratory contracted with my managed care company. Therefore, we may be asked to pay for certain laboratory tests needed to monitor treatment and determine the optimal time to retrieve the eggs.

____

We understand that we are responsible for any charges that were pre-approved by our insurance company but were subsequently denied due to change of benefits, exceeding coverage limits, or any other cause.

____

We understand that if we choose to attempt a subsequent fresh IVF cycle before payment has been made to GIH by our health plan for the prior cycle, we will be responsible for medical expenses incurred for the subsequent fresh cycle. GIH will file my insurance claims and make appropriate patient refunds once reimbursement is received. We have met with the financial counsellor at Gulu Independent Hospital and fully understand and accept our financial obligations.

__________________________________________________________________

Patient's signature

Date

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Spouse/Partner's signature

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Notary Public/Witness' signature

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OVERVIEW FOR IVF PATIENTS

IN VITRO FERTILIZATION AND EMBRYO TRANSFER

Introduction
In vitro fertilization and embryo transfer (IVF-ET) was first successfully used in humans over 20 years ago; since then, thousands of children have been conceived using this technology. IVF is a procedure designed to enhance the likelihood of conception in couples for whom other fertility therapies have been unsuccessful or are not possible. It involves multiple steps resulting in the insemination and fertilization of oocytes (eggs) in our laboratory. The embryos created in this process are placed into the uterus for potential implantation. Each stage of the procedure is associated with specific risks, as outlined below.

Benefit of Therapy
IVF-ET is an elective medical treatment. IVF may provide a couple who has been otherwise unable to conceive with a chance to establish a pregnancy.

Risks of Therapy

Superovulation stimulates egg development

The "superovulation" techniques used in IVF are designed to stimulate the ovaries to produce several eggs (oocytes) rather than the usual single egg as in a natural cycle. Multiple eggs increase the potential availability of multiple embryos (fertilized eggs) for transfer and ultimately the probability of conception.

The medications required to boost egg production may include, but are not limited to the following: Lupron (gonadotropin releasing hormone-agonist), Antagon (gonadotropin releasing hormone-antagonist), Follistim, Repronex or Gonal-F (FSH, follicle stimulating hormone), Humegon (combination of FSH and LH, luteinizing hormone), and Pregnyl or Profasi (hCG, human chorionic gonadotropin). Each is administered by injection only. Lupron, Follistim, Repronex and Gonal-F are given subcutaneously (beneath the skin), and the others are intramuscular injections (into the muscle). Risks associated with injectable fertility medications may include but are not limited to, tenderness, infection, haematoma, and swelling or bruising at the injection site.

Risks associated with the medications may include, but are not limited to, allergic reactions, hyperstimulation of the ovaries (mild, moderate or severe), failure of the ovaries to respond and cancellation of the treatment cycle.

There are situations that can occur during a stimulation that may necessitate cancelling your IVF cycle and stopping treatment for a period of time. This occurs because the ovaries produce either too many or too few eggs in response to drug stimulation protocol. Although we realize that this can be a big disappointment, at times it is necessary to discontinue the use of the medications to avoid the possibility of complications and to afford you the best chance of future success. If cancelling the cycle becomes necessary, you will be told to stop your injections. No hCG injection will be given and no egg retrieval will occur. You will be asked to schedule an appointment with your physician to make decisions for future treatment cycles.

When ovulation induction medications are used in fertility therapy, the ovaries are coaxed to produce more than one egg to the point of maturity. Consequently, hormone levels of oestrogen and progesterone reach much higher than normal values. When the oestrogen level becomes mildly to moderately elevated, side effects that may be experienced include, but are not limited to, fluid retention with slight transient weight gain, nausea, diarrhoea, pelvic discomfort due to enlarged cystic ovaries, breast tenderness, mood swings, headache and fatigue.

If the oestrogen level rises excessively and hCG is administered to trigger final maturation of the eggs, the following more serious complications may result from severe ovarian hyperstimulation syndrome:

Excessive fluid retention with fluid in the abdomen and/or chest cavity;
Thrombosis of arteries and/or veins (formation of blood clots) which may lead to stroke, embolus, or potentially fatal complications;
Excessively enlarged ovaries, which have the possibility of rupturing or twisting (a surgical emergency)

Any of the three problems listed above may require prolonged hospitalisation.

Because of the potential for such severe complications, it is important that we carefully monitor your response to these medications. This monitoring also allows your physician to determine when the eggs are ready for the next stage, oocyte (egg) retrieval. Monitoring includes frequent blood drawing for estradiol (oestrogen) and possibly progesterone, LH and FSH levels. These blood tests will take place over approximately a twelve-day period. Risks associated with blood drawing may include, but are not limited to:

Pain at the site of needle stick
Tenderness or infection of the skin
Bruising or scarring of the site of blood draw
Development of a blood clot in the vein (thrombosis, thrombophlebitis)

The second portion of the monitoring phase in IVF involves the use of intravaginal ultrasound to track follicular growth. The eggs develop inside fluid-filled cysts of the ovaries called follicles, which enlarge as the eggs mature. Ultrasound studies usually begin after an oestrogen response has been measured and continue on a frequent basis until oocyte (egg) retrieval. The ultrasound studies are performed using a vaginal probe. Vaginal sonograms carry no appreciable risk but may cause slight discomfort, particularly as you near the point of ovulation.

Ovarian stimulation with the fertility medications causes multiple follicles to develop. This is desirable in IVF because as the number of eggs increases, the chance for success increases. Multiple embryos can also increase the risk of multiple pregnancy. Approximately 20-25% of pregnancies with IVF will be multiple. Most of these will be twins, but triplets, quadruplets or even greater multiple pregnancies can occur. A procedure called "selective reduction of pregnancy" has been performed in several medical centers across the country in selected cases of triplets or more. Selective reduction is not offered on site or by GIH staff. More information on this procedure and recommended centers is available on request.

A possible association between the use of fertility drugs and an increased risk of developing ovarian cancer has been raised by some investigators. The exact risk, if any, is unknown.

Retrieving the oocytes (egg retrieval)

For IVF, collection of eggs is usually performed under transvaginal ultrasound guidance. To accomplish this, a needle is inserted (under IV sedation) through the vaginal wall into the ovaries using ultrasound to locate each follicle. The follicular fluid is drawn up into a test tube to obtain the eggs. Although patients are given pain medications intravenously and are carefully monitored by an anaesthesiologist, some women may experience some discomfort during the procedure. Generally, the oocyte (egg) retrieval takes 30-45 minutes. Patients are usually discharged home within a couple of hours after the retrieval. Risks of oocyte (egg) retrieval may include but are not limited to the following:

Potential reactions from the drugs and procedures used in the administration of anesthesia.
Risks associated with the passage of the needle through the vagina into the ovaries (including infection, bleeding, inadvertent damage to adjacent structures including, but not limited to, the bowel, bladder, blood vessels, ureter, uterus or ovary(ies), and adhesion formation (internal scarring) following the procedure. Although uncommon, significant bleeding or damage to the bowel may occur, and surgery may be required to repair such damage; this is a very uncommon event. Rarely, infection may become severe enough to require hysterectomy and/or removal of one or both ovaries.

Collecting and Preparing the Sperm

A semen sample will be obtained from the partner by masturbation on the day of the oocyte (egg) retrieval. This is usually obtained while the retrieval is being performed. Abstinence from ejaculation for two to four days prior to providing this semen specimen is recommended. After the specimen is produced, the sperm will be prepared for inseminating the collected eggs in our laboratory. A second sample of fresh semen may be needed the day of or the day after egg retrieval to inseminate egg(s) that were not mature or did not initially fertilize. Because this can be a stressful time period for men, the man/partner may be unable to produce a specimen when needed. If a frozen specimen is not available and a fresh ejaculate cannot be produced, any eggs collected will be discarded. Men who feel that they may have difficulty producing a semen specimen have the opportunity to have their specimens frozen by our laboratory ahead of time for use in this situation.

Insemination of Eggs and Embryos Culture

Following egg retrieval, the follicular fluid is immediately transferred to the adjacent laboratory for identification of eggs, evaluation, and preparation for insemination. In the process of collecting the follicular fluid, it is typical for a large number of eggs to be retrieved. It is strongly recommended that all of these eggs be inseminated to maximize the number of embryos available for subsequent transfer. Any objection(s) to policy should be stated in writing and attached to the IVF-ET consent form with the understanding that pregnancy success may be reduced. Otherwise, the prepared sperm will be added to each egg and they will be allowed to incubate overnight under controlled laboratory conditions. The next day, each egg is evaluated for evidence of fertilization. However, it is possible that no eggs are fertilized. If this happens, the laboratory staff will re-inseminate the eggs or perform intracytoplasmic sperm injection (ICSI) in hopes of obtaining embryos for transfer. If fertilization still does not occur, the eggs will be discarded and the remainder of the procedure will be cancelled. In the case of severe male factor, the couple may be asked to consider the option of using anonymous donor sperm (obtained through a licensed sperm bank for use as a "backup" or secondary sperm source) if it is not possible to obtain sufficient sperm from the partner at the time of fertilization.

The eggs that have fertilized will be allowed to develop for one or more additional days under controlled laboratory conditions before they are placed inside the woman's uterus. Depending upon the couple's wishes, some fertilized eggs or embryos may be frozen and stored for future use.

After the embryos are transferred to the womb, the woman will continue progesterone supplementation that begins on the evening of your egg retrieval procedure. Progesterone can be taken as a combination of oral troches and rectal/vaginal suppositories or by injections. Administration of these medications after egg collection has been shown to create a more favourable uterine environment for the embryos, which therefore increases pregnancy rates. Side effects of progesterone may include, but are not limited to the following:

vaginal dryness
bloating, breast tenderness
depression, mood swings
delay of menses

Synthetic progesterone-like medications have been associated with certain birth defects. By using only natural progesterone, the risk of drug-induced birth defects is significantly reduced. It is important to note, however, that birth defects occur in approximately 3% of spontaneously-conceived pregnancies in the USA. Therefore, use of natural progesterone does not guarantee a child without a birth defect.

Transferring Embryos to the Uterus

Embryos are transferred to the uterus through a small tube (catheter). This procedure is much like a pap smear and does not require any anesthesia and is usually painless. The embryos are placed in a small amount of fluid inside the catheter, which is passed through the cervix at the time of a speculum examination. The embryos are placed in a manner so they reach the top part of the uterus. The number of embryos transferred depends on individual circumstances of the couple, and this decision will be made collectively by you, your physicians and the embryologist. Two to four embryos may be transferred in one treatment cycle.

Embryo transfer can cause mild cramping. Although unlikely, during the embryo transfer the embryo(s) may be displaced through the cervix (causing loss of embryos) or into the fallopian tubes (causing possible tubal pregnancy). There is a small risk of bleeding or infection as a result of the transfer procedure.

After transfer, the woman may get dressed and leave after a brief recovery period. A pregnancy test will be done twelve to fourteen days after the transfer, regardless of the occurrence of any uterine bleeding.

The transfer of several embryos increases the probability of success. If you do not make arrangements for the number of embryos to transfer at the time recommended, your chances for pregnancy could decrease. A multiple embryo transfer also increases the risk of a multiple pregnancy. Any multiple pregnancy carries an increased risk of miscarriage(s), premature labour and premature birth as well as an increased financial and emotional cost. Pregnancy-induced high blood pressure and diabetes are more common in women pregnant with more than one foetus. Prolonged hospitalisation may be necessary for these pregnant women and for the mother and babies after delivery. In the event of multiple pregnancies, the option of selective reduction will be reviewed with the couple. Tubal (ectopic) pregnancy is also possible, and a combination of normal pregnancy and ectopic pregnancy may occur. A tubal pregnancy is a condition that may require laparoscopy or major surgery for treatment. Like spontaneous (natural) conceptions, pregnancies that arise through IVF may result in miscarriage. In the event of a miscarriage, a dilatation and curettage (D&C) may be necessary.

Couples going through therapy must choose and formalize their choice in the appropriate GRS consent form by indicating one of the following options for handling of any remaining embryos:

Freezing (cryopreservation) of remaining embryos for use by the couple in future treatment cycles
Anonymously donating the embryos for use by another infertile couple(s), if the donating couple and the donated embryos meet the screening criteria (You will not receive any money for this donation, nor will GRS "sell" them. GRS reserves the right to cryopreserve (freeze) any donated embryos as well as the right to discard any donated embryos if a suitable woman cannot be identified to receive the embryos)
Allowing the embryos to develop in the laboratory until they perish, at which time they would be disposed of in a manner consistent with professional ethical standards and applicable legal requirements (This usually occurs within six to eight days after egg collection)

Other issues

Any assisted reproduction process or technique can be psychologically stressful. Significant anxiety and disappointment may occur. We encourage you to consider short-term supportive counselling during this time and we are happy to provide you with a list of psychiatrists, psychologists, counsellors and social workers who may help you through this difficult time.

A substantial time commitment is required by both partners to complete an entire course of IVF therapy. It will be necessary for couples to adjust their schedules to undergo the required testing and therapies associated with IVF-ET. It is the responsibility of the woman to report to our office as scheduled for repeated ultrasound examinations and blood tests over several days or weeks before and after the expected time of egg collection. It is the responsibility of the man to be available at the time identified by the physician to provide sperm.

Theoretical concerns & potential for success:

Unfortunately, neither conception nor a successful outcome of pregnancy is guaranteed by the IVF-ET procedure. There are many reasons why pregnancy may not occur with the IVF-ET procedure. In fact, there are complex and largely unknown factors that limit pregnancy rates following assisted reproductive techniques. Some of the known reasons for failure may include, but are not limited to:

1. There may be a failure to recover an egg because:

a. follicles that contain mature eggs may not develop in the treatment cycle

b. ovulation has occurred before time of egg recovery

c. one or more eggs cannot be recovered

d. pre-existing pelvic scarring and/or technical difficulties prevent safe egg recovery

2. The eggs that are recovered may not be normal

3. There may be insufficient semen to attempt fertilization of the recovered eggs because the man is unable to produce a semen specimen, because the specimen contains an insufficient number of sperm to attempt fertilization, because the laboratory is unable to adequately process the specimen provided, or because the option to use a donor sperm as a "backup" was declined;

4. Fertilization of the eggs to form embryos may fail even when the egg(s) and sperm are normal;

5. The embryos may not develop normally or may not develop at all. Embryos that display any abnormal development will not be transferred;

6. Embryo transfer into the uterus may be difficult/impossible, or implantation(s) may not occur after transfer, or the embryo(s) may not grow or develop normally after implantation;

7. Any step in the IVF-ET process may be complicated by unforeseen events, such as hazardous or catastrophic weather, equipment failure, laboratory conditions, infection, human error and the like.

In the event the couple should die before embryo transfer, the embryo(s) will be discarded unless other provisions are made in writing.

When pregnancy occurs following IVF, it will typically be a normal pregnancy. However, there is always a risk of abnormal pregnancy, miscarriage, blighted ovum, ectopic pregnancy or premature delivery. This is because the process of IVF-ET does not protect against such normal occurrences. Congenital abnormalities, genetic abnormalities, mental retardation or other birth defects which occur in approximately 3 % of spontaneously-conceived pregnancies may still occur in children born following assisted reproductive techniques. A large review of a subset of children born following assisted reproductive procedures found the incidence of developmental anomalies similar to a control group of children spontaneously conceived. Women with multiple pregnancies have a much higher risk of complicated pregnancies, which may include the following: toxaemia, pre-eclampsia, miscarriage, premature labour and delivery, stillbirth, birth defects, and other complications.

Alternatives to IVF-ET:

Depending upon the individual and unique cause(s) of infertility for each couple, the chance of conception through alternative means, including intrauterine insemination (IUI) and medicinal therapy, other than IVF-ET may or may not exist. Possible success rates of these alternatives may vary depending upon the type and severity of the cause of the infertility. For some couples, it may even be possible to conceive spontaneously without a physician's help. You should discuss these alternative treatment methods with your physician before you proceed with IVF-ET therapy.

PRE-IVF SEMEN ANALYSIS

Although you may already have a recent semen analysis report available , we require that an IVF semen analysis be performed at GIH Reproductive Specialists in order to insure the best possible number of fertilized eggs. GIH operates andrology and endocrinology laboratories to support its assisted reproductive technologies. The staff will work closely with your physician to coordinate your care and provide you and your wife complete urological and assisted reproductive technology services.

HOW TO SCHEDULE AN APPOINTMENT:

Call (0025647132279 (between 8:00 a.m. and 4:30 p.m.) to make an appointment. Appointments are available from 8:00 to 11:00 a.m., Monday through Friday.

WHAT TO EXPECT DURING YOUR APPOINTMENT:

Step 1 When you arrive you will be asked to sign in at the front desk. Tell the receptionist that you have an appointment for an IVF semen analysis.
Step 2 You will be called to come back to the lab area where you will be shown into one of the specimen collection rooms.
Step 3 You will then be provided with additional instructions on specimen collection. The specimen collection rooms are set up to provide you a private and comfortable environment in which to produce the specimen. The rooms are equipped with magazines and videos.

REQUIREMENTS FOR PRODUCING A SPECIMEN
AT HOME FOR DROP OFF AT THE LABORATORY
We prefer that the specimen be collected at GIH; however, if this is uncomfortable or inconvenient for you it may be acceptable for you to collect the specimen at another location and deliver it to the laboratory. In order to do this you must adhere to the following guidelines:

Deliver the specimen at your appointment time. Let the scheduler know that you will drop off the specimen at the time of your appointment so the laboratory will be prepared to perform the analysis immediately.
Deliver the specimen within one hour of ejaculation (consider traffic and travel distance).
You must have a suitable sterile specimen container (sterile and non-toxic to sperm). You or your spouse or partner may pick up a specimen container from the laboratory ahead of time, or you can purchase a sterile specimen cup (like the ones used for urine specimens) from a pharmacy.
Label the specimen cup with your name and place the sealed specimen cup in a paper bag. Protect the specimen from extremes in temperature and from sunlight during transport. It is best to keep the specimen at 75° to 85°F during transport.

REQUIREMENTS FOR PROPER COLLECTION OF A SPECIMEN
Refrain from ejaculation for 2 to 4 days before producing the specimen for analysis. Longer or shorter periods of abstinence will result in specimens that yield incorrect indications and are not acceptable for analysis.

The semen specimen should be produced by masturbation. Wash your genitals and hands to minimize the chance of contamination of the specimen. Do not use lubricants or saliva when masturbating since potential toxicity to the sperm can adversely influence the results. Collect the ejaculate directly into the specimen cup and replace the lid immediately to prevent contamination. Do not produce the specimen by coitus interruptus (having intercourse and withdrawing the penis prior to ejaculation) or by oral sex. Both activities can lead to a suboptimal specimen, which may yield falsely abnormal semen analysis results.

Do not collect the specimen with a regular condom since they contain chemical that are toxic to sperm. If masturbation is absolutely unacceptable to you, please obtain a special semen collection device from GIH. These devices consist of a special non-toxic condom and a test tube for transporting the semen to the laboratory. There is also a small funnel to 47 use in transferring the semen from the condom into the test tube and detailed instructions on how to use the device. You and your spouse or partner may use this device in the specimen collection room at GIH if this is convenient for you.

NOTES
Try not to sit in hot tubs or spas during the three months before the treatment cycle.

Use of drugs, alcohol, cigarettes or chewing tobacco should be kept to an absolute minimum during the three months before the treatment cycle. In some cases, the treatment may need to be postponed if a herpes lesion is present at the time of semen collection.

If you have a fever of 101° F or higher within three months before the treatment cycle, sperm quality may be adversely affected. The sperm count and motility may appear normal, but fertilization may not occur. If you become sick, please take your temperature morning and night and take Tylenol every four hours to keep your temperature down. Report the fever to your nurse.

LABORATORY TESTS
IVF Semen Analysis - This test provides an indication of how your semen compares with the general population. The following parameters are measured in a semen analysis: volume and consistency of semen, sperm count, percentage of sperm that are progressively motile (moving in a straight line), the strict morphology (structural appearance) of the sperm and sperm survival. A semen analysis does not diagnose fertility or infertility but provides a relative measure of semen quality compared to the general population of men. It can suggest possible conditions associated with reduced fertilization at IVF and indicate the need for ICSI.

Reporting Test Results - Allow at least seven days for your physician to receive and review your test result.

Sperm Cryopreservation - Sperm can be frozen and stored for future use in either artificial insemination or IVF. Arrangements for this are made with a sperm bank. This frozen sperm can be used as a backup should future ability to produce viable sperm be diminished. Some reasons for considering sperm cryopreservation include the following: as a precaution when undergoing cancer therapy or prior to a vasectomy if there is a possibility that you may want to have children in the future. Furthermore, during vasectomy or testicular biopsy, it is wise to freeze a specimen of the sperm that is available at the time of the procedure to avoid the potential need for a second surgery. Specimens obtained during surgery will contain low numbers of sperm and can be used only in conjunction with IVF with ICSI.

How Many Specimens Should be Frozen? - This is decided on a case-by-case basis, depending on the reason for freezing the semen and the semen quality. If semen quality is poor, it is likely that the frozen specimen can be used only in IVF. When this is the case, a single ejaculate is usually as good as several ejaculates since very few sperm are needed for IVF. A single specimen can be frozen in multiple vials for use in multiple IVF attempts. If semen quality is very good and a single ejaculate produces enough sperm for several inseminations, then freezing several ejaculates is a wise option. Although freezing several ejaculates costs more initially, the use of the frozen specimen in artificial insemination is much less expensive, less invasive and has far fewer risks associated with it than the use of IVF.

Requirements - Before semen can be frozen, a consent agreement must be completed. The consent agreement outlines the responsibilities of the laboratory and of you in the process of maintaining the frozen specimen(s). Specimen collection requirements are the same as described above, with special attention to collecting a clean specimen free of contamination

INFORMED CONSENT

IN VITRO FERTILIZATION AND EMBRYO TRANSFER THERAPY

We, ________________________________ (referred to herein as "Patient") and _________________________________ (referred to herein as "Spouse/Partner"), have elected to undergo in vitro fertilization and embryo transfer (IVF) therapy at Gulu Independent Hospital (referred to herein as GIH). We certify that the following statements represent our understanding and acceptance of conditions, responsibilities and risks involved in the use of IVF therapy.

RISKS AND LIMITATIONS
We understand and agree to assume the risks involved in IVF therapy, which may include, but arent limited to, the following:

Repeated blood sampling causing a risk of redness, small bruises, and, to a lesser extent, infection or thrombosis
The utilization of fertility drugs to induce ovulation may impose certain risks including physical as well as emotional pain or discomfort, blood clotting, ovarian tumours/cancer and the related risks of ovarian hyperstimulation syndrome, which can cause death;
Material risks of egg retrieval procedure: DEATH, RESPIRATORY ARREST, CARDIAC ARREST, BRAIN DAMAGE, DISFIGURING SCAR, PARAPLEGIA OR QUADRIPLEGIA, TOTAL OR PARTIAL PARALYSIS, LOSS OF FUNCTION OF ANY LIMB OR ORGAN, SEVERE LOSS OF BLOOD, ALLERGIC REACTION OR INFECTION. These are material risks attendant to any surgical procedure. The specific physical risks involved regarding surgical egg retrieval from Patient's ovaries include pain and discomfort, aesthetic complications, surgical complications such as injury to the bowel, blood vessels, or other structures, bleeding and/or infection. Bleeding or other injuries or complications resulting from the egg retrieval may require an invasive surgical procedure to correct the complication. Any such complication or its correction could affect future fertility;
During the egg retrieval procedure, the physician/surgeon may become aware of conditions or complications which were unforeseen or not known before the start of the procedure. I therefore authorize and request the physician/surgeon and such assistants or physicians as may be present to perform such additional or different operations or procedures as are necessary or appropriate in the exercise of professional judgment to diagnose, treat, or cure such conditions;
There is a much higher probability of a multiple gestation pregnancy (twin, triplet, quadruplet) outcome using IVF as opposed to other treatments for infertility;
If pregnancy results from this procedure, there is a possibility of complications from pregnancy and parturition or other adverse consequences. The possibility of complications during pregnancy and parturition are greater in the case of a multiple gestation pregnancy.

We acknowledge and agree that within the human population a certain percentage (approximately 4%) of children are born with physical and/or mental defects and that the occurrence of such defects is beyond the control of GIH physicians and staff. We therefore agree that GIH, its officers, directors, agents and employees, including physicians and staff do not assume responsibility for the physical or mental characteristics of a child or children born as a result of IVF therapy.

We acknowledge and agree that our acceptance into the IVF program and our continuing participation is within the sole discretion of GIH. We understand that we can withdraw from the program at any time by written notice to GIH without affecting the availability of other present or future medical evaluations or treatments within GIH. A GIH physician may terminate IVF therapy when, in their best medical judgment, it is prudent to do so. The physician in charge will consult with Patient and Spouse/Partner prior to such termination and will discuss options for future therapy.

We acknowledge our understanding that most couples who require IVF therapy may not be covered by medical insurance for some or all of this treatment. We affirmatively represent we are financially able to pay for this therapy and are responsible for all medical costs incurred during our evaluation and treatment at GIH. We will promptly pay all charges due GIH, which we may incur.

We are aware that there will be charges we must pay before the first medications are administered in any separate treatment cycle. If we are found not to have third party insurance coverage for IVF, we understand that attempting to obtain insurance reimbursement for non-covered charges may constitute fraud. We agree not to submit these bills for uncovered charges to our carrier for reimbursement.

We acknowledge and accept that GIH is a teaching facility and that the IVF staff will include attending physicians, fellows, residents, interns, scientists, technicians, nurses and medical students. We consent to allowing GIH IVF staff or other medical personnel to observe laboratory procedures or any other treatment or procedure performed on Patient or Patient's behalf. Furthermore, it is possible that our participation in this program may aid in the development of techniques that may help other infertile couples and/or may yield new and useful information for medical science. Therefore, we consent to the collection and publication of information and data and the making of photographic and/or audiovisual tapes during the course of our IVF therapy for use in advancing medical education and research. However, under no circumstances will our identity be revealed.

We consent to the use and subsequent disposal of eggs or embryo(s) that are judged to be not developing or viable, unfertilised eggs, and/or eggs fertilized by too many sperm in approved research. In addition, we consent to the disposal of or use of other cells, body tissue and fluids that may have been obtained during the IVF process for research purposes.

We understand and accept that we also have the following choices as to handling of potentially viable embryos which are not used in our IVF therapy and authorize the GRS physicians and/or staff involved in this procedure to: (please mark and place initials of both Patient and Partner beside one choice)

_____ ______ Cryopreserve (freeze) the embryos for our use at a future time. An additional consent form outlining additional requirements and fees for cryopreservation must be signed if this option is selected.
_____ ______ Discard the excess viable embryo(s) in any manner deemed appropriate by the IVF team.
_____ ______ Donate the embryos to another infertile woman. We recognize that donated embryos will be frozen for storage. This option is only possible if we complete additional medical and genetic screening. We consent that GIH may dispose of the donated embryos in any manner deemed appropriate by GIH if a suitable woman cannot be identified to receive them.
_____ ______ Use the embryos in research projects permitted under the policies of GIH Reproductive Specialists policies and applicable legal requirements.

COMPREHENSION OF CONSENT AGREEMENT
We have read and understand this document and additional information provided. We have discussed this document and additional information with Dr.___________________ , who has provided us ample opportunity to ask any questions regarding IVF therapy and who has answered our questions to our satisfaction. We acknowledge that no guarantee or assurance has been made to the results that may be obtained. We further acknowledge that this document is by no means a complete record of our conversations with GIH physician(s), faculty and staff and are satisfied that we are sufficiently advised and informed to make this decision.

CONSENT
We understand and accept the conditions, risks and limitations of participating in the GIH IVF program. We therefore voluntarily consent to undergo the procedures associated with this therapy. We are 18 years of age or older.

RELEASE
We agree to absolve, release, indemnify, protect and hold harmless GIH, its officers, directors, agents and employees from any and all liability for any adverse outcome, however remote, arising from IVF therapy including but not limited to complications related to the IVF therapy, complications related to pregnancy and/or childbirth, and/or the birth of a physically or mentally deficient child. Additionally, we release, discharge and acquit harmless GIH, its officers, directors, agents and employees from any and all liability in connection with subsequent disputes arising between patient and spouse/partner or any other third party in connection with the control and/or disposition of any fertilized eggs or embryos in existence as a result of this therapy, or the custody and/or support of any child(ren) born as a result of this therapy.

_______________________________________________________________________
Patient's signature Date
_______________________________________________________________________
Spouse/Partner's signature Date
_______________________________________________________________________
Notary Public/Witness' signature Date

GIH Reproductive Specialists
IVF Shared-Risk Program

WHAT IS THE IVF SH