The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial (NCT03307356) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial
United States10 participantsStarted 2018-01-10
Plain-language summary
Options for childbearing are limited for the thousands of women in the United States who suffer from absolute uterine factor infertility. Uterine transplantation is an emerging treatment that provides hope for these individuals.
In the Penn UNTIL trial, the investigators plan to perform uterus transplants on five women who will ultimately undergo embryo transfer, pregnancy, delivery, and then transplant hysterectomy.
This trial is accepting women in need of a transplant and also women who are interested in being a live donor.
For more information please visit: https://clinicalresearch.itmat.upenn.edu/clinicaltrial/4821/congenital-abnormalitiesfemale-infertility-penn-ut/
Who can participate
Age range21 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. XX-bearing individual diagnosed with Uterine Factor Infertility (UFI) a
✓. Age 21-40
✓. Lives in Philadelphia region for the duration of the trial
✓. Received counseling regarding alternatives to uterine transplant such as adoption or surrogacy
✓. Intact ovaries
✓. Vaginal length \>6 cm (average vaginal length established with dilators)
✓. Body mass index \<35 kg/m2
✓. Fluent in the English Language
Exclusion criteria
✕. Previous multiple major abdominal/pelvic surgery
✕. Severe endometriosis
✕. History of hypertension, diabetes mellitus, thrombophilia or other clotting or bleeding disorders, significant heart, liver, kidney or central nervous system disease
What they're measuring
1
Recipient: Successful engraftment of deceased or living donor uterus
Timeframe: Assessed 6 months after transplant
2
Recipient: Live-born child per embryo transfer
Timeframe: Assessed up to 35 weeks post-embryo transfer