Vorzimer, Masserman and Chapman, A Guide to Infertility Options

Guide to Infertility Options Through
Assisted Reproductive Technologies

There are a daunting number of innovative techniques available today for infertile couples to begin their families. As couples have exhausted clinical and surgical treatments, many have turned to the assistance of third parties to bring their children into the world. Many are finding the value in utilizing the assistance of surrogate mothers, egg donors and sperm donors. In more recent years, couples are taking interest in using embryos from other more fortunate couples who have an excess number of embryos to donate. The purpose of this article is to provide a basic guide through the myriad of procedures available, and to provide some information on the important steps involved in the administration of specific treatments.

I. WHAT TO DO FIRST

1. Determine Legality of Surrogacy/Egg Donation - Speak to a reproductive law attorney to determine the status of surrogacy and egg donation in your state. Currently, five states and the District of Columbia find surrogacy arrangements to be either unlawful or will find the agreements unenforceable. It is important that the attorney consider the laws of both the state where the Intended Parents and Surrogate reside.

2. Verify Insurance - Confirm that proper coverage is in place for any catastrophic illness and/or medical consequences of the infertility procedures. Determine whether your policy, and/or that of the surrogate or donor, will cover any or all medications and infertility treatments. Many insurance companies are now denying medical maternity expenses to women serving as surrogates. Other insurance companies reserve the right to seek reimbursement from the Intended Parents for any maternity benefits paid on the surrogate's behalf. It is also imperative that the Intended Parents take the appropriate steps, in advance of birth, to have their child added to their own health insurance policy upon delivery.

3. Itemize Costs - Be sure you understand all of the costs associated with the selected infertility program. There may be hidden costs associated with fees for additional treatment cycles, time lost from work (for both the surrogate and possibly her spouse), travel to specialists, child care expenses, or unforeseen medications.

4. Obtain Informed Consent - Obtain informed consent agreements from the surrogate/donor (and if married, their spouses), the fertility program and/or clinic you have chosen. Consult with an attorney to clarify the risks and ramifications of executing an agreement with a doctor, clinic and/or agency. Be sure you have been told and understand all the medical procedures and risks associated with your particular infertility treatment.

5. Execute Legal Contracts -Work with an attorney knowledgeable in reproductive law to draft, negotiate and finalize legal agreements as needed with infertility specialists, agencies and third-party donors or surrogates. Ensure that your surrogate and/or egg donor is represented by competent, independent legal counsel, who must issue a legal clearance letter, indicating that the surrogate (and her husband if she is married) and/or donor understands and appreciates the issues set forth in the contract, is proceeding with the arrangement volitionally and without any coercion or undue influence. Among the myriad of issues to be discussed, the parties must: a) Establish financial responsibility of the parties; b) Establish the financial and legal responsibilities of the parties; c) Ensure that social disease testing takes place; d) Address the ownership and disposition of any remaining embryos; e) Address what records must be maintained and by whom; f) Establish the parameters of acceptable conduct by the parties throughout the arrangement; g) Address insurance issues such as life, medical and disability insurance; h) Identify the mechanism to be utilized to finalize parental rights; i) Address issues of pre-natal testing and reduction; j) Establishment of a trust account, compensation to be received by the Surrogate and what expenses will be reimbursed; and k) Agree upon what contact, if any, the surrogate and/or donor will have with the child.

6. Medical and Psychological Screening - The Intended Parents, the Surrogate and her spouse, and the Egg Donor must complete a full medical examination which includes a variety of tests, including genetic and social disease testing, including HIV. Recently, a new test has been developed to detect retroviruses in semen or blood: Polymerase Chain Reaction ("PCR"). This new detection system tests the DNA, even in its earliest stages of development, for the HIV virus. The benefit of using PCR is that retroviruses may be detected after only four weeks of exposure, as contrasted with the standard testing in which the virus could only be detected after three to six months of exposure. The result is that the usual six-month quarantine requirement of ova, semen and embryos is no longer necessary, allowing couples to quickly proceed with their chosen infertility program. In addition to the medical screening, psychological testing and evaluation of the Surrogate and Egg Donor is also essential. This screening should be done by licensed social workers or psychologists who perform a variety of tests to determine the suitability of the surrogate and donor for the Intended Parents, among other issues relevant to the chosen method of third party assisted reproduction.

7. Discuss All Possible Scenarios - Among the numerous reasons to associate with a team of professionals is to ensure that all participants have considered the host of issues which can arise in any collaborative reproduction arrangement. These scenarios can include: a) decisions on the number of embryos to transfer and decisions relating to selective and fetal reduction; b) guardianship instructions in the event of the demise of one or both Intended Parents; c) life support instructions for the surrogate; d) what the participants will tell their children; e) what contact will be permitted between the participants; f) disposition of excess embryos; g) anonymity and confidentiality issues; and h) the utilization of pre-natal testing, including preimplantation genetic diagnosis and amniocentesis.

8. Surrogacy Programs - There are a number of surrogacy programs offering specialized services to couples considering the use of collaborative reproduction. Great care must be paid in the screening of these agencies as there are significant variances in the screening methods and protocols used. Since there is little regulation in this field, it is imperative that a diligent background review of the program take place and, when comparing programs, be certain to identify the specific services offered by each. Further, programs differ as to: a) anonymity and confidentiality issues; b) professional and agency fees; c) ongoing reporting obligations; and d) the option to select the professionals who will participate in the arrangement. As a result, whether an agency is used or the arrangement is handled independently, it is imperative that the program be carefully screened for its background, qualifications and success rates.

9. Keep a Sense of Humor - Try not to let the clinical nature of the following list of treatments discourage you from having fun with your partner. Work together to keep a positive attitude, and do not allow an infertility problem to take the magic out of making your baby.

II. TYPES OF ASSISTED REPRODUCTIVE TECHNOLOGIES

The following overview of rapidly expanding innovative treatment technologies is intended to provide Intended Parents with a perspective of how medical protocols will coordinate with a third-party reproductive arrangement. As a result, the technologies are discussed with an eye towards coordinating with a surrogate and/or egg donor in order to achieve a pregnancy.

SURROGACY GENERALLY: Despite negative press reports and myths associated with surrogacy, more than twelve thousand couples in the United States have realized the benefits of conceiving healthy children through surrogacy. There are several forms of surrogacy arrangements:

A. In "traditional surrogacy," a surrogate mother is artificially inseminated with the sperm of the Intended Father. This method, chosen by many women incapable of providing viable eggs and carrying a child to term, is often the most cost-effective form of surrogacy. It is also the least invasive method for a surrogate, who can avoid painful shots and other medication associated with surrogacy.

B. In "gestational surrogacy," in vitro fertilization is used to form embryos with the Intended Parents genetic material which are then transferred to surrogate. This procedure is often used when the Intended Mother is infertile due to blocked fallopian tubes or endometriosis but can produce eggs.

C. In "gestational surrogacy with egg or sperm donation," the Intended Parents contract separately with a surrogate and an egg and/or sperm donor after screening and testing of the parties has been completed. Embryos are formed through in vitro fertilization, and the fertilized embryos are transferred to the surrogate in order to carry the child to term.

There are a multitude of medical, legal and psychological issues surrounding the formation of a surrogacy arrangement, many of which are outside the purview of this article. It is important that surrogates are properly tested and screened by professionals well in advance of entering into a formal surrogacy contract. It is critical that Intended Parents are properly informed about the procedures involved in the formation of the surrogacy arrangement, the medical issues surrounding the conception of the child and the legal procedures involved in the finalization of parental rights.

The laws in the United States vary from state-to-state regarding the regulation and legality of surrogacy, and it is essential that all parties enter into a valid surrogacy contract reflecting these intricacies. In particular, the laws of California are arguably the most favorable due to recent case law. In the most recent and extraordinary surrogacy case to date, a California Appellate Court held that parental relationships are established in a surrogacy arrangement when the Intended Parents initiate and consent to medical procedures, even when there is no genetic relationship between them and the child. Buzzanca v. Buzzanca, 72 Cal. Rptr. 2nd 280 (1998) ("Jaycee B."). Accordingly, this case ensures that the Intended Parents in either a gestational or traditional surrogacy arrangement, with performance occurring in California, even if using donor eggs and/or sperm, will be adjudicated as the legal parents.

A. IVF / GESTATIONAL SURROGACY The in vitro fertilization process itself was born in 1978 by Drs. Steptoe and Edwards and was marked with the arrival of Louise Brown. Through this procedure, the Intended Father's sperm and the Intended Mother's egg are fertilized in the laboratory, and the fertilized embryo is transferred into the uterus of either the Intended Mother or the Surrogate.

Basic Steps:

1. "Fertility drugs" are administered to stimulate the ovaries to produce an optimal amount of eggs. Dosage and types of drugs vary, and are most often taken for 7 to 10 days. The most frequently administered ovulation drugs include Clomid, Humegon, Pergonal and a follicle stimulating hormone known as Metrodin. In some cases, Lupron is given to suppress and/or control ovulation induction. Ultrasounds are used to observe the development of ovarian follicles, in order to estimate the number of eggs which will be produced. Blood tests are used to record levels of estrogen (should increase as follicles develop), progesterone (should be low after ovulation) and/or luteinizing hormone (LH) (dramatic increase indicates ovulation). When the follicles have properly matured, surrogate mothers are given a final hCG shot (a hormone known as "human chorionic gonadotropin"), and the egg retrieval process will occur approximately 36 hours later, the time when most women normally ovulate.

2. "Egg Retrieval" is accomplished via two basic methods. First, eggs may be removed in a physician's office or an outpatient surgical center through a minor surgical procedure commonly referred to as a transvaginal ultrasound aspiration. In this case, an ultrasound probe is used to guide a needle into the follicles and suction eggs. In rare cases, eggs are removed through laparoscopy, which usually requires a general anesthetic, and requires an small incision in the lower abdomen to guide the laparoscopy into the ovarian follicles.

3. "Egg Fertilization" occurs either immediately after the eggs are aspirated, or from several hours to one day after the eggs are retrieved. Eggs are examined for maturity and then placed in a laboratory dish with the Intended Father's sperm. The laboratory dish is kept at 98.6 degrees. In cases where sperm problems are a factor, intracytoplasmic sperm injection (ICSI) may be accomplished by injecting a single sperm into one of the Intended Mother's eggs in order to achieve fertilization. Within 12 hours, a fertilized embryo should have divided into two cells. Eight-cell embryos, considered the optimal number of cell divisions prior to transfer into the uterus, usually occurs within 44 to 72 hours.

4. "Embryo Transfer" involves the transfer of fertilized embryos into the uterus of the Recipient Mother or the Surrogate with a long, thin catheter. The process is accomplished on an outpatient basis within about 10 to 20 minutes. Couples must decide how many embryos to transfer during each embryo transfer cycle, as well as whether to cryopreserve (freeze) excess embryos.

5. "Selective/Fetal Reduction" - For couples involved with in vitro fertilization or any other innovative treatment technology involving the transfer of more than one embryo per cycle, selective reduction is one of the most difficult decisions a couple may have to face during the course of treatment. Selective reduction involves the removal of one or more fetuses, either due to a physical/genetic abnormality or to reduce a pregnancy, e.g. from a triplet to a twin pregnancy. While most couples are prepared to welcome one or more children into their home and anxiously await positive pregnancy results, far fewer are prepared for the significant risks associated with multiple pregnancies. Bed rest, miscarriage and premature birth are just a few of the risks commonly associated with multiple births. In the event a selective reduction is performed, there is still some risk to the viability of the remaining fetuses.

The number of embryos transferred per cycle is based upon the physician's recommendation regarding, among other things, the quality of resulting fertilized embryos. Some couples utilize preimplantation genetic diagnosis to detect potential genetic abnormalities prior to transfer or for sex selection. Other couples minimize the potential for selective reduction by asking the physician to transfer only two embryos per cycle. However, there may be important medical reasons to transfer more than two embryos in order to achieve a pregnancy. Due to the increased risks associated with multiple births, it is critical that the number of embryos transferred is discussed in detail with the infertility specialist prior to beginning treatment. Moreover, the issue of selective reduction should be addressed in the surrogacy contract.

B. GIFT

A GIFT (gamete intrafallopian transfer) transfer involves the injection a mixture of eggs and sperm directly into the fallopian tube of the surrogate mother. After the injection, fertilization and embryo implantation occurs as it would in a normal pregnancy.

This procedure is one of the only methods condoned by the Catholic Church, which denounces the use of artificial technologies to create children as immoral, unethical and unnatural. According to the Vatican, sexual intercourse is an essential element of reproduction, with conception occurring within the wife. To accommodate this, physicians use a specially designed condom which contains several holes. Following intercourse, the husband's remaining sperm in the condom is placed in a dish with eggs retrieved from his wife. Both are immediately placed back into the wife's fallopian tubes so conception occurs within the body. Because fertilization occurs within the fallopian tube, conception is construed as a gift of life from God as in any pregnancy. The GIFT procedure is particularly useful for women with endometriosis and where infertility is caused by male and/or immunological problems. There are usually two eggs transferred during each GIFT procedure. The success rate is generally about 5-10% higher than IVF success rate.

C. ZIFT

In rare cases, some physicians recommend using a zygote intrafallopian transfer (ZIFT). This procedure involves the removal of eggs through aspiration, fertilization in the laboratory and the subsequent transfer of fertilized embryos to the fallopian tube rather than the uterus. This method may be useful in cases where the infertility problem is based upon particularly poor egg quality, severe endometriosis or a male factor where the sperm fails to properly penetrate the egg.

D. ARTIFICIAL INSEMINATION / TRADITIONAL SURROGACY Artificial insemination involves the transfer of sperm directly into the surrogate mother's reproductive tract. This process is most successful in cases where the couple's infertility problem has been identified as the inability of the woman to produce usable eggs or the functional failure of her ovaries and carry a pregnancy to term.

Basic steps:

1. "Testing/Evaluation" - In order to determine whether an artificial insemination procedure will be advantageous, a complete medical evaluation is required. First, a semen analysis is conducted to determine sperm quality, count and motility, and a sperm antibody test is also performed. Other basic disease testing is also recommended, including that for human immunodeficiency virus (HIV), hepatitis and sexually transmitted disease testing. The surrogate must also undergo a pelvic exam and disease testing (as must her husband, if she is married). It is possible to confirm that the fallopian tubes are free of obstruction through a hysterosalpinogram, hysteroscipy or laparoscopy, which involve the surgical insertion of tiny catheters to allow a physician to view the inside of the tube.

2. "Ovulation" - It is critical that the insemination takes place on the appropriate point of ovulation during the surrogate mother's cycle, which is determined by the physician with the surrogate's assistance. Ovulation is usually detected through an LH surge kit and basal body temperature (BBT) charts. If the surrogate does not ovulate regularly, the physician may recommend medication to regulate and induce ovulation.

3. "Insemination" - The most common form of artificial insemination involves the injection of sperm into the surrogate mother's cervix by a physician or nurse with a syringe. Some surrogates, if comfortable with the process, elect to perform the insemination privately at home using a syringe provided in a home insemination kit. A second method, intrauterine insemination (IUI), involves the injection of sperm directly into the uterus. With an IUI insemination, the sperm is "washed" prior to the insemination in order to separate sperm from the seminal fluid which can cause severe pain if injected directly without prior treatment. Washing and releasing sperm into a sterile fluid prior to injection into the cervix also avoids infectious chemicals and bacteria which may otherwise cause added complications or infection. The type of insemination procedure chosen should be identified in the surrogacy agreement and should be explained in the medical informed consent document.

E. SPERM AND/OR EGG ("OOCYTE") DONATION

In the event that the Intended Parents are not able to contribute genetically to the formation of embryos, many couples have considered utilizing sperm and/or egg donors to form embryos. In order to avoid future disputes, it is important that an attorney and/or agency maintain proper confidential records regarding medical screening and legal contracts.

In the event that a medical question presents itself in the future necessitating contact with a donor, it is important that an objective third-party, often an attorney or agency, maintains a confidential record of current addresses for all parties involved in a donation agreement for perpetuity. Finally, even if the donor is known (i.e., a close friend or relative), it is important that the risks and ramifications of the agreement are memorialized in writing to avoid misunderstandings and disputes.

1. Sperm Donation

Couples who have experienced failed artificial insemination procedures and have identified male factor infertility may consider contracting with a sperm donor. Sperm donation is most successful in cases where the couple's infertility problem has been identified as the Intended Father's low sperm count and/or poor motility. It is also one of the most affordable and least invasive methods of infertility treatment. Artificial insemination is also useful for diabetics suffering from retrograde ejaculation (where the sperm is released incorrectly into the bladder), men suffering from impotence or semen deficiencies. Donor sperm is injected directly into the Recipient Mother's cervix. It is important to properly evaluate male factor infertility through a complete physical examination by a physician.

If a sperm donor is considered, a variety of sperm banks offer donor screening and semen storage services which must be carefully evaluated. The medical history, age and medical testing results should be evaluated prior to contracting with a sperm bank or specific donor. Although most sperm banks operate on an anonymous donor basis, an extended profile of the donor's personality and interests is often available. Couples may consult an attorney to review any agreements, informed consent documents or waivers provided by the sperm bank.

In other cases, couples decide to work with a known donor who is either usually a friend or relative. In these instances, a sperm donor agreement is usually drafted, outlining such issues as confidentiality, medical and psychological screening, potential parental rights and compensation. As a final note, finalization of parental rights with respect to the sperm donor is generally not necessary in most states due to either a statute and/or agreement terminating any rights the donor may have to the child.

2. Egg Donation

Egg Donation is a relatively new procedure typically involving the removal of one or more eggs from a donor, fertilizing the eggs with the sperm of the Intended Father and implanting fertilized embryos into the uterus of the Recipient Mother. This procedure is useful for women who have experienced premature ovarian failure or are otherwise unable to produce healthy eggs. As discussed in further detail below, in cases where the Intended Mother is unable to carry a child to term, some couples will elect to transfer the fertilized embryos to a surrogate mother.

Similar to sperm donation discussed above, donated eggs are most commonly obtained through agencies experienced in the screening and testing of suitable donors. It is important that the specific protocol of the agency is explained in detail prior to contracting with a donor. Some couples obtain eggs through known donors, most frequently close friends, sisters or other relatives. Finally, as with sperm donation, an agreement is usually drafted, outlining such issues as confidentiality, medical and psychological screening, potential parental rights and compensation. Again, finalization of parental rights with respect to egg donation, at least in California, is not necessary due to the agreement terminating any rights the donor may have to the child.

Basic steps:

1. "Medical Testing & Screening" - Prior to entering into a legal contract, an egg donor completes a full medical exam which includes a variety of medical tests, including genetic and social disease testing. Some programs recommend that donors have given birth to at least one child, are between the ages of 21 and 34 and are not receiving any public assistance. Psychological testing and/or evaluation is also recommended by some doctors and infertility programs. It is important that a donor is fully screened prior to entering into a legal contract in order to avoid financial commitment to a donor who is not capable of viable donation.

2. "Medication" - Egg donors are given hormones by injection approximately two to three weeks prior to egg retrieval. The monitoring physician will carefully determine the development of eggs through ultrasound treatments and blood hormone tests. As the donor's eggs are stimulated in this manner, the Recipient Mother is also given medication to synchronize her cycle with the donor's cycle in order to allow for proper implantation of fertilized embryos. In some cases, the Recipient Mother is given a hormone called estradiol in order to thicken the lining of the uterus in preparation for implantation.

3. "Egg Retrieval" -As previously discussed above, eggs are retrieved through an ultrasound guided needed in a minor surgical outpatient procedure. The aspiration of eggs occurs approximately 36 hours after the administration of the final hCG shot. Retrieved eggs are examined by the laboratory, graded for maturity, and prepared for in vitro fertilization as discussed above.

F. ENUCLEATED CYTOPLASMIC TRANSFER

This innovative treatment technology, currently conducted by a few physicians and clinics on an experimental basis, involves the transfer of cytoplasm from the donor's eggs to eggs removed from the Intended Mother's body through aspiration. This unique procedure allows a woman who has age-related problems with her eggs to use her own genetic material within the cytoplasm of a younger, healthier woman's egg. Whether a resulting child will have any physical or psychological abnormalities as a result of the transfer of cytoplasm remains unclear.

III. FINALIZING YOUR PARENTAL RIGHTS

State statues vary regarding the type of legal procedures needed to finalize parental rights; that is, the method to ensure the Intended Parents' legal rights are perfected and their names are placed on the birth certificate. As a result, it is important to identify the type of finalization documents needed. For example, in California egg donation arrangements, there are no legal documents needed to finalize parental rights for the Intended Mother/ Recipient Mother who carries the child to term. California recognizes the Recipient Mother as the legal mother, and her name is therefore placed directly on the birth certificate with her husband (if married) as the legal parents. As most cases are finalized in California, the following discussion focuses on the established procedures of that state.

With respect to any surrogacy arrangement, there are specific steps that must be accomplished in a timely manner to ensure that parental rights are finalized and the names of the Intended Parents appear on the original birth certificate at the time of the birth. Due to the legal complexities involved in finalizing parental rights, it is advisable to seek the assistance of an experienced reproductive law attorney.

1. Timing - It is important to begin the process of finalization of parental rights approximately halfway through the pregnancy. On occasion, couples express a desire to wait until the last trimester to file legal documents. However, delaying the initiation of the legal process could cause problems with the hospital and insurance paperwork, creating unnecessary paperwork and anxiety. This is particularly relevant due to the fact that advances in medical technologies have resulted in an increased number of multiple births. Thus, it is critical to begin the process early enough to allow time for all the parties to review and sign relevant documents, as well as ample time (usually about a month) for individual county courts to process the legal judgments.

2. Circulate Pleadings - All parties, including the Intended Parents, the Surrogate and her Husband, as well as their respective counsel, must review and sign the legal documents prior to filing them with the court. Most counties require stipulations and judicial forms authorizing the court to enter the Judgment without a formal hearing. Only in rare instances do judges require a personal appearance of any of the parties stipulating to a Judgment of Maternity and Paternity. Each county requires specific documents in order to obtain a proper and timely judgment.

3. Legal Filings & Fees - Pleadings are filed in the state and the county where the child will be born. In most states, hospital administrative staff are responsible for registering births with the local Department of Vital Statistics. As previously discussed, each county varies with respect to the type of documents to be filed, as well as the amount of time it will take for the court to process the final judgment. In most cases, judgments are obtained within a month. Counties vary regarding filing fees for purposes of stipulated judgments, with fees ranging from $400 to $700 for filing the complaint and issuance of several copies of the certified judgment.

4. Hospital Documentation - Once the legal judgment is obtained, hospital administrators appreciate an advance certified copy of the judgment for the medical file as well as a copy for the birth certificate administrator. Attorneys also should provide a letter with the accompanying legal paperwork providing identifying information about the Intended Parents and the Surrogate. This information provided to the hospital staff and insurance companies may also be necessary during the pre-registration stage at the hospital, as well as for obtaining delivery room and nursery arm bands required by most hospitals in order to have access to the baby.

5. Obtaining Birth Certificates - Birth certificates are issued by the local Department of Vital Statistics and are then recorded in state archives. In most cases, original birth certificates are received within 10 days to 2 weeks. For international couples, this process may be expedited in order to finalize parental rights and obtain valid passports, allowing them to return to their home countries in a timely manner with their babies. In the event that a birth certificate must be amended due to post-birth judgments or out-of-state births, an additional 6 to 8 month delay is typical in order to receive an amended birth certificate.

6. Passport Issues - For overseas couples, an expedited Birth Certificate and a United States Passport for their child may be obtained, usually within 10 days. Upon receipt of the Certificate of Live Birth from the hospital, this document must be delivered to the Department of Vital Records for the issuance of a certified copy of the Birth Certificate. Once the certified copy of the Birth Certificate is obtained, one may then proceed to either the Federal Building or certain U.S. Post Offices and complete a passport application. The following will be required: proof of citizenship (passport), proof of identity (e.g. driver’s license), plane tickets and two identical passport photos of the baby. In most instances, the request for an expedited passport can be processed in 24 hours. To obtain a passport from the Intended Parents’ own country, the local embassy/consulate should be contacted. In most situations, a passport may be obtained for the child from the Intended Parents’ home country in 7 to 10 days.

IV. TAKING THE NEXT STEP TOWARD PARENTHOOD

The abundance of options available to couples willing to undergo infertility treatment to create their children mystify even the most arduous researcher. There are subtle variations to each and every one of the innovative treatment technologies discussed above, and this article serves merely as a guide through the confusing terminology and technologies currently available to hopeful parents. What is most important is that each week children are born to parents who previously never thought they would experience the joy of childbirth and their own children. Due to the complicated issues presented by medical technology growing at such record speed, careful and informed decisions must be based on current information with the guidance of experienced attorneys, counselors and physicians.