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Procedure

Uterine Transplant for Uterine Factor Infertility (UNTIL Trial)

N/A
Waitlist Available
Led By Kathleen E O'Neill, MD, MTR
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Compatible blood type with recipient for Deceased Donor
XX-bearing individual diagnosed with Uterine Factor Infertility (UFI) aged 21-40
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 2 years
Awards & highlights

UNTIL Trial Summary

This trial is for women with absolute uterine factor infertility who want to get pregnant. Uterine transplantation is an emerging treatment that provides hope for these individuals. The trial is also accepting women who are interested in being a live donor.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include those associated with major surgery such as pain, bleeding or infection; risks related to immunosuppressive therapy like increased susceptibility to infections; complications during pregnancy; and psychological impact.

UNTIL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood type matches that of the organ recipient.
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I am a woman aged 21-40 diagnosed with Uterine Factor Infertility.
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I have both of my ovaries.
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I am HPV negative or have been vaccinated against HPV.
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My vaginal length is more than 6 cm.
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My cervix appears normal, though I may have a polyp.
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I am between 18 and 50 years old.
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My uterus is normal and healthy.
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My uterus is considered normal by a gynecologic surgeon.
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My recent pap test was normal and I don't have HPV.

UNTIL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Living Donor: Survival post-donation
Recipient: Live-born child per embryo transfer
Recipient: Successful engraftment of deceased or living donor uterus
Secondary outcome measures
Living Donor: Genitourinary tract complications
Living Donor: Intraoperative/postoperative/pregnancy/postpartum complications
Living Donor: Need for reoperation
+7 more

UNTIL Trial Design

1Treatment groups
Experimental Treatment
Group I: Uterine TransplantationExperimental Treatment1 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.

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,991 Previous Clinical Trials
42,875,775 Total Patients Enrolled
Kathleen E O'Neill, MD, MTRPrincipal InvestigatorUniversity of Pennsylvania

Media Library

Uterine Transplant (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03307356 — N/A
Uterine Factor Infertility Research Study Groups: Uterine Transplantation
Uterine Transplant (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03307356 — N/A
Uterine Factor Infertility Patient Testimony for trial: Trial Name: NCT03307356 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the requisite criteria for participants of this research endeavor?

"This medical trial seeks 5 XX-bearing individuals aged 21 to 40 with Uterine Factor Infertility (UFI). These people must reside in the Philadelphia region for the duration, possess functional ovaries, a vaginal length of at least 6 cm upon dilatation, and have a BMI below 35 kg/m2. In addition, participants should be conversant in English; if they possess a cervix or previously had one, HPV status needs to be negative or vaccinated against. Last but not least, patients need to agree to comply with all screening processes as outlined by the protocol."

Answered by AI

Is eligibility restricted to those over 40 for this experiment?

"This trial is accepting participants aged between 21 and 40; however, there are additional studies available for those younger than 18 or older than 65. Specifically, 14 clinical trials exist for minors while 35 have been developed to accommodate senior citizens."

Answered by AI

Is this scientific experiment still admitting new participants?

"The information on clinicaltrials.gov specifies that recruitment for this trial has ended, with the first post dated to January 10th 2018 and last update issued October 13th 2022. Nonetheless, 246 other medical studies are currently in search of volunteers."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Excited to see what comes out of this trial.
PatientReceived no prior treatments
~2 spots leftby Jul 2029