Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Factor Infertility
Absolute Uterine Factor Infertility (AUFI) is due to congenital or surgical absence of a uterus or the presence of a nonfunctional uterus. Until 2014, the only option for women affected by Absolute Uterine Factor Infertility (AUFI) was adoption or surrogate motherhood. Uterine transplant is a new form of transplant to treat AUFI. The technique of uterus transplant was developed in Sweden with the transplantation of the uterus from a living donor to a woman affected by AUFI. Approximately 80 uterine transplantations have been performed, more than 50 of which have occurred within the past 3 years. To date, 34 children have been born from mothers who have received a living donor uterine transplant. This is a prospective study to treat Absolute Uterine Factor Infertility (AUFI) through uterine transplantation utilizing a uterus from a living or deceased donor resulting in live birth. A total of 10 biologically female (XX Karyotype) subjects will receive a uterine transplant.
• Women who are diagnosed with Absolute Uterine Factor Infertility (AUFI) and who have at least one functioning ovary.
• Women of childbearing age (20-40 years old) who are biologically female (XX karyotype).
• Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
• Subjects will have negative testing for Gonorrhea Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (Subjects with previously treated STDs will be included if the infection is no longer present and has no impact. If a subject develops an STD/infection pre-operatively, she will be treated and monitored for a period of 3 months until she is no longer affected. She will then become eligible for transplant. If a subject develops an STD/infection after transplant/during pregnancy she will be treated appropriately. Prior to the embryo transfer the patient will be tested and treated if necessary. Any patient with an active STD/infection will be ineligible for any elective procedure until she is tested and treated appropriately.)
• Subjects who are HSV-2 negative or who have a history of HSV-2 with no current symptoms. Subjects may require preventative maintenance per study doctor discretion.
• Subjects have received counseling regarding all fertility options and alternatives to uterine transplant such as adoption or surrogate pregnancy.
• Subjects are willing to undergo in-vitro fertilization to obtain the necessary 4 viable embryos required for eligibility for transplant if they have not already banked 4 viable embryos.
• Subjects have been evaluated by a fertility specialist and determined to have good ovarian reserve and reproductive potential.
• Subjects must agree that in the event of withdrawal from the study while the transplanted uterus is in place, unless she is enrolled in an equivalent uterine transplant program, she will be required to undergo a hysterectomy for her own safety.
⁃ Subject meets psychological recipient criteria.
⁃ Subject must be willing to complete questionnaires about their infant's growth and development and return them to the study team.
• Women must be between 25-65 years of age. If a subject is less than 40 years old she must be certain that she does not wish to carry more children, and she will attest to this decision.
• Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
• Subjects will have negative testing for Gonorrhea, Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (Subjects with previously treated STDs will be included if the infection is no longer present and has no impact. If a subject develops an STD/infection pre-operatively, she will be treated and monitored for a period of 3 months until she is no longer affected. Any patient with an active STD/infection will be ineligible for any elective procedure until she is tested and treated appropriately.)
• Subjects who are HSV-2 negative, or have a history of HSV-2 but with no current symptoms. Subjects may require preventative maintenance per study doctor discretion.
• Subjects will have a normal uterus on sonogram and CT.
• Subjects will have normal psychological donor criteria (if living).
• Subjects will have had at least one prior full term live birth.