Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility (NCT02656550) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility
United States38 participantsStarted 2015-11-11
Plain-language summary
This study aims to investigate the treatment of absolute uterine infertility (AUI) due to congenital or surgical absence of a uterus or presence of a nonfunctioning uterus. The investigators will follow a model based on a Swedish study to enroll 20 women with functioning ovaries and successfully transplant the uterus from either a living or cadaveric donor, with the goal of live birth after transplantation.
Who can participate
Age range20 Years – 35 Years
SexFEMALE
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Inclusion criteria
✓. Women diagnosed with Absolute Uterine Infertility (AUI) and intact native ovaries.
✓. Women of childbearing age 20-35.
✓. Human papillomarvius negative or received vaccination for human papillomarvius virus (HPV). Subjects with a history of HPV in the past must show a negative history since and test negative at screening.
✓. A subject who is negative for Gonorrhea, Chlamydia and Syphilis.
✓. A subject with the history of Herpes (HSV-2) with no current symptoms. Subject may require preventative maintenance per study doctor discretion.
✓. Subjects have received counseling regarding infertility alternatives to uterine transplant such as adoption or surrogate pregnancy.
✓. Willing to undergo in-vitro fertilization and medically cleared for in-vitro fertilization.
✓. Evaluated by a fertility specialist and determined to have good ovarian reproductive potential and ability to carry fetus to term.
Exclusion criteria
✕. Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test.
✕. Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or CellCept.
✕. Subject with existing hypertension, per investigator's discretion.
✕
What they're measuring
1
Number of successful live births after uterine transplant and IVF.