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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

Must not have

Severe endometriosis for Uterine Transplant Recipient Participant

History of hypertension, diabetes mellitus, thrombophilia or other clotting or bleeding disorders, significant heart, liver, kidney or central nervous system disease for Uterine Transplant Recipient Participant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 2 years post-hysterectomy

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe endometriosis affecting my uterus.

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I have a history of high blood pressure, diabetes, clotting disorders, or major organ disease.

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I have two normal kidneys confirmed by imaging.

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I refuse to receive blood or blood product transfusions for a uterine transplant.

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I have had several major surgeries in my abdomen or pelvic area.

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I have had more than one C-section or surgery to remove fibroids.

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I have had cervical surgery such as a cone biopsy or LEEP.

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My uterine cavity is abnormal.

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I have a history of high blood pressure, diabetes, clotting disorders, or major organ disease.

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I refuse to receive blood or blood product transfusions.

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I have not had multiple major surgeries on my uterus.

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My BMI is over 35.

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I have a significant condition like diabetes or lupus.

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I have had several major surgeries in my abdomen or pelvis for a uterine transplant.

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I have never had cervical surgery like a cone biopsy or LEEP.

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I have severe endometriosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 2 years post-hysterectomy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 2 years post-hysterectomy

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 2 years post-hysterectomy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Living Donor: Survival post-donation

Recipient: Successful engraftment of deceased or living donor uterus

Secondary study objectives

Living Donor: Symptomatic claudication of buttock or legs

Recipient: Neonatal growth

Recipient: Pregnancy complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 26Eligibility criteria met