Clinical trial for Infertility of Uterine Origin
Official title Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)
ClinicalTrials.gov ID: NCT04026893
What this study is testing
- What it's testing
- The study wants to see if a uterus transplant from a deceased donor is safe and can allow pregnancy in women who cannot carry a child because of uterine problems.
- Who it's for
- Women of reproductive age with healthy ovaries who cannot carry a pregnancy due to uterine infertility and who are emotionally and socially stable.
- What's involved
- Participants will have eggs taken, fertilized in a lab, and embryos frozen. If they have at least six healthy embryos, they may wait for a donated uterus. After the transplant and a six‑month check‑up, frozen embryos will be implanted. Pregnancy will be monitored closely. Interviews and surveys will also be done to learn about the experience.
- Time commitment
- The whole process takes about 22 to 36 months, including screening, egg work, waiting for a donor uterus, transplant, six months of follow‑up, embryo transfer, pregnancy, and a final check after the uterus is removed.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- Evidence of AUFI diagnosed by BWH gynecologist
- Ability to produce at least 6 euploid embryos for cryopreservation
- BMI ≤ 30
- GFR 60 or greater in any patient including those with a single kidney
- PRA 20% or less
You likely can't join if
- Active smoking, alcohol use or use of illicit drugs
- Inability to follow a strict medication dosing schedule post-transplant and adhere to required follow-up appointments.
- Any co-morbidities which would increase surgical risk, risk of pregnancy or the risk of taking anti-rejection medications as determined by the...
- Active infection: HIV, Hepatitis B, Hepatitis C
- Inadequate blood vessels to support the transplanted uterus.
- Prior extensive abdominal or pelvic surgery
See the full eligibility criteria
- Evidence of AUFI diagnosed by BWH gynecologist
- Ability to produce at least 6 euploid embryos for cryopreservation
- BMI ≤ 30
- GFR 60 or greater in any patient including those with a single kidney
- PRA 20% or less
- Deemed stable and capable of undergoing transplant by the transplant team to include psychiatry, social work, and transplant coordinator and study doctors to assure compliance with treatment
- Evidence to be compliant with follow-up and immunosuppression
- Partner willing to undergo psychological evaluation and receive immunizations as recommended
- Stable home environment to support a child
- Active smoking, alcohol use or use of illicit drugs
- Inability to follow a strict medication dosing schedule post-transplant and adhere to required follow-up appointments.
- Any co-morbidities which would increase surgical risk, risk of pregnancy or the risk of taking anti-rejection medications as determined by the Maternal Fetal Specialist and Transplant Surgeon.
- Active infection: HIV, Hepatitis B, Hepatitis C
- Inadequate blood vessels to support the transplanted uterus.
- Prior extensive abdominal or pelvic surgery
- Presence of pelvic kidney
- History of abnormal PAP
- HPV related vulvar, vaginal or cervical dysplasia
- Evidence of genital condylomata
- History of PID
- One or more living biological children
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.