The phrase “third-party reproduction” refers to the use of eggs, sperm, or embryos that have been donated by a third person (donor) to enable an infertile individual or couple (intended recipient) to become parents. Donors may be known or anonymous to the intended recipient. “Third-party reproduction” also includes traditional surrogacy and gestational carrier arrangements. Traditional surrogacy refers to a treatment in which a woman is inseminated with sperm for the purpose of conceiving for an intended recipient. The surrogate in this scenario has a genetic and biological link to the pregnancy she might carry. In contrast, a gestational surrogate (also called a gestational carrier [GC] or uterine carrier) is an individual in which embryos created by the intended parents are transferred into the surrogate’s uterus, which has been prepared hormonally to carry a pregnancy. The gestational surrogate has no genetic link to the fetus she is carrying. Traditional surrogacy arrangements often are perceived as controversial with the potential to be complicated both legally and psychologically. Despite the requirement for in vitro fertilization (IVF) to create embryos, the utilization of a gestational surrogate, legally, is a lower-risk procedure and is the more common approach conducted in the United States.
Third-party reproduction is a complex process requiring consideration of social, ethical, and legal issues. The increased use of egg donation has required a reconsideration of the social and ethical impact this technology has had on prospective parents, their offspring, and the egg donors themselves. Surrogacy has been acknowledged within the reproductive-medicine community as well as by the American Society for Reproductive Medicine (ASRM). Surrogacy arrangements nevertheless remain controversial and are subject to both legal and psychosocial scrutiny. This booklet will discuss the options for third-party reproduction, reviewing sperm donation, egg donation, embryo donation, and both traditional surrogacy and gestational surrogacy.
Artificial insemination using donor sperm has been practiced for over a century, although the first published reports about the practice were in 1945. Over the past 10 years, the use of donor sperm has decreased as the use of intracytoplasmic sperm injection (ICSI) for the treatment of male infertility has become widespread. Since the late 1980s, with the emergence of acquired immunodeficiency syndrome (AIDS), artificial donor insemination has been performed exclusively with frozen and quarantined sperm. Current FDA and ASRM guidelines recommend that sperm be quarantined for at least six months before being released for use.
Currently, therapeutic-donor insemination (DI or TDI) is appropriate when the male partner has severe abnormalities in the semen parameters and/or reproductive system. These abnormalities include both obstructive (caused by a blockage of the ejaculatory ducts) and nonobstructive (due to testicular failure) azoospermia (absence of sperm), which may be congenital or acquired. Examples of obstructive azoospermia include congenital absence of the vas deferens or previous vasectomy. Examples of nonobstructive azoospermia include primary testicular failure or secondary testicular failure due to previous radiation treatment or chemotherapy. Severe oligospermia (decreased sperm count) or other significant sperm or seminal fluid abnormalities also are indications for DI. DI also is indicated if the male has ejaculatory dysfunction or if he is a carrier or affected with a significant genetic defect and would prefer not to pass this gene on to his children. DI may be used if the female is Rh-sensitized and the male partner is Rh-positive. DI often is used in the treatment for a single woman who desires a pregnancy but who lacks a male partner.
Sperm donors should be of legal age and ideally less than 40 years of age to minimize the potential hazards of aging. Traditionally, donors have been anonymous; however, the donor also may be known or directed to the couple or single woman. The ASRM believes it is important that both anonymous donors and donors known to the recipient–though not necessarily intimate sexual partners–undergo the same initial and periodic screening and testing process. However, the FDA only requires that anonymous sperm donors be screened for risk factors for, and clinical evidence of, communicable disease agents or diseases.
A donor is ineligible if either screening or testing indicates the presence of a communicable disease or of a risk factor for a communicable disease. A comprehensive medical questionnaire to evaluate the health of a donor and review his family medical history is the primary focus in selecting a donor. Particular attention is paid to the potential donor’s personal and sexual history to exclude those males who are at high risk for communicable disease including HIV, hepatitis, and other sexually transmitted diseases. A family medical health history is obtained for at least two generations of family members. Prospective donors then undergo a physical examination with screening for visible physical abnormalities, as well as testing for sexually transmitted diseases. Routine blood analysis includes documentation of the donor’s blood type. Current FDA regulations require infectious-disease testing to be performed and noted to be negative within 7 days of all sperm donations. The sperm are then collected by masturbation, concentrated into small volumes of motile sperm, and frozen until used. For anonymous donors, testing for Treponema pallidum (syphilis), Chlamydia trachomatis, Neisseria gonorrhoeae, HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-I and HTLV-II, CMV, hepatitis B surface antigen, and hepatitis C antibody are performed prior to donation and thereafter should occur at six-month intervals, according to FDA guidelines. Although the FDA exempts directed sperm donors from the six-month retesting requirement, the ASRM recommends that directed donors be retested just as anonymous donors are retested. In contrast to the other communicable diseases, a positive CMV result does not make the sperm donor ineligible, since many programs allow his sperm to be used with CMV-positive recipients. Comprehensive genetic testing is impractical; however, ethnically based genetic testing is standard in most sperm banks.
It is recommended that all sperm donors, anonymous and directed, have a psychological evaluation and counseling by a MHP. The assessment should seek any psychological risks and evaluate for financial and emotional coercion. The donor should discuss his feelings regarding disclosure of his identity and plans for future contact. Psychological testing may be performed, if warranted.
Ideally, the sperm donor should undergo a semen analysis, and the test sample should be thawed to evaluate post-freezing/thawing semen parameters. Sperm susceptibility to damage with freezing varies among individuals, as well as among samples of a given donor. Donors are selected if the post-thaw semen parameters meet a minimum standard. In general, specimens should contain a minimum of 20 to 30 million motile sperm per milliliter after thawing. Post-thaw motility is generally in the range of 25% to 40%. There are two types of samples offered by most sperm banks. Intracervical insemination specimens (ICI) are prepared for intracervical inseminations only and must be washed if used for intrauterine inseminations. Although sperm preparations for ICI are available, the majority of reproductive endocrinology practices perform intrauterine insemination (IUI). IUI samples are pre-washed for intrauterine insemination. Both ICI and IUI semen samples are frozen and quarantined for a minimum of 180 days. They are not released until the donor is retested for communicable diseases and the results are negative.
In addition to the medical information that is obtained from the donor, donors are asked to provide detailed information about their personal habits, education, hobbies, and interests. Sperm banks may provide pictures of the donor and video or audiotapes from the donor. Donors may identify themselves as open to contact from any child conceived through DI once a child reaches legal age.
Before proceeding with donor insemination, a couple must be evaluated thoroughly for the causes of infertility with a comprehensive medical history and physical exam for both partners. It is recommended that the woman have documentation of ovulation with either an ovulation predictor kit or a basal body temperature chart. In addition to a pelvic examination, a hysterosalpingogram (HSG) or sonohysterogram (SHG) will evaluate further the uterine cavity and patency of the fallopian tubes.
Insemination may be timed based on a woman’s natural cycle or in conjunction with an ovulation induction cycle and should occur close to the time of ovulation. The procedure is relatively simple and is performed in the physician’s office. The woman is positioned on the examination table as if in preparation for a pelvic examination. The physician or nurse then places the speculum into the vagina to visualize the cervix. The semen sample is drawn up into an insemination catheter attached to a syringe. With IUI (Figure 3), the washed semen specimen is placed through the cervix and into the uterine cavity. This enables a higher concentration of sperm to reach the uterine cavity and fallopian tubes, which is where fertilization occurs.
The pregnancy rates with donor insemination depend on many factors. These include the age of the female recipient and the presence of other female fertility factors such as endometriosis, tubal disease, or ovulatory dysfunction. In general, the monthly chance of pregnancy ranges from 8% to 15%. A number of studies have demonstrated that the pregnancy rates with IUI are greater than ICI when frozen donor semen is used. The risk of birth defects as a result of conceiving with donor insemination is no different than natural conception and is in the range of 2% to 4%.
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