Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility
Running, not enrolling · Not applicable
Conditions studied: Absolute Uterine Infertility
In brief
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.
Key facts
- Study ID
- NCT02656550
- Run by
- Baylor Research Institute
- People needed
- 38
- Starts
- 2015-11-11
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-03-23
Who can join
Age: 20 and older, up to 35. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Must have the ability to fund, either through third party coverage or through other their own personal financing, any expenses associated with assisted reproduction services provided to them.
- Meets physiological recipient criteria
You may not qualify if…
- 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.
- Subject who has a history of solid organ or bone marrow transplant.
- Subject who has history of cancer in last five years.
- Subject with a body mass index >30.
- Subject with an active infection.
- Subject who is seropositive for HIV, HBV, HCV
- Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator.
- Subject unwilling or unable to comply with study requirements.
- Subject unable to undergo in-vitro fertilization or not cleared for transplant.
- Subject who has smoked within the last 12 months.
- Subject who has alcohol or drug abuse within 12 months of screening.
- Subject with any pre-existing clinical or medical conditions that would pose the subject at an increased risk, as per the investigator's discretion.
Where it is running
- Baylor University Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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