Uterine Transplant for Uterine Factor Infertility

(UNTIL Trial)

Overseen by Kathleen E O'Neill, MD, MTR

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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/

Research Team

Kathleen E O'Neill, MD, MTR

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for women aged 21-40 with uterine factor infertility (UFI) who have intact ovaries and live in the Philadelphia area. They must understand English, have a BMI under 35, adequate social support, and be willing to follow the trial procedures. Donors can be women aged 18-50 with compatible blood types and normal uterine anatomy who are also from the Philadelphia area.

Inclusion Criteria

Compatible blood type with recipient for Living Donor Participant

Negative flow cytometric crossmatch with recipient for Living Donor Participant

Has current health insurance for Living Donor Participant

Exclusion Criteria

I have not had a serious infection in the last 3 months.

I quit smoking at least 3 months ago and am considering a uterine transplant.

History of significant psychiatric illness for Uterine Transplant Recipient Participant

Treatment Details

Interventions

• Uterine Transplant (Procedure)

Trial Overview The University of Pennsylvania UNTIL trial is testing uterus transplants as a treatment for absolute uterine factor infertility. Women will receive a transplant, undergo embryo transfer leading to pregnancy and delivery, followed by removal of the transplanted uterus.

Participant Groups

Group I: Uterine Transplantation Experimental Treatment 1 Intervention

Women will undergo extensive medical and psychological screening. Five women that meet all inclusion and exclusion criteria will undergo ovarian stimulation, oocyte retrieval and will create embryos that will be stored for future use. Women will then undergo uterine transplantation from a donor. Following transplant women will be closely monitored for complications (including infection and rejection). If no complications arise, or complications that do arise can be treated, attempts at pregnancy will begin approximately 6 months after transplant. Pregnancy in the setting of uterine transplant requires directly placing embryos directly into the uterus.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+