Uterine Transplantation for the Treatment of Uterine Factor Infertility

NCT02573415 | Active Not Recruiting DMC

• 1 other identifier: FLA 14-085
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study aims to enroll ten subjects who will undergo deceased donor uterine transplantation at Cleveland Clinic. We estimate that fifty to one hundred patients with uterine factor infertility will need to be screened to identify 10 appropriate subjects. There are seven phases involved in this study: Primary and Secondary Screening, Medical Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up

Conditions

Primary Uterine Infertility

Outcome Measures

Primary Outcomes (1)

• Number of successful live births after uterus transplant and IVF

  Full term birth by cesarian section after IVF followed by uterus transplant

  2 years after transplantation

Study Arms (1)

Uterus Transplantation

EXPERIMENTAL

Women will undergo deceased donor uterine transplantation after IVF.

Procedure: Uterus Transplant

Interventions

Uterus Transplant PROCEDURE

transplant of a deceased donor uterus.

Uterus Transplantation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must meet criteria for uterine factor infertility
• Prior hysterectomy
• Congenital absence or malformation of the uterus preventing pregnancy c, Infertility due to uterine damage from prior injury or infection
• Must be between the ages of 21-45 and the embryos must have been produced between the age of 21-39. (age at the time the embryos are produced, not current age)
• Must be willing to undergo a psychiatric and social work pre-transplant evaluation
• Must be willing to undergo general anesthesia, in vitro fertilization, major gynecologic surgery, pregnancy with potential high risk complications, cesarean delivery and eventual hysterectomy to remove the graft
• Must be willing and able to receive potent immunosuppressive medications and must be able to follow standard infection prophylaxis protocols
• Must be willing to receive standard vaccinations such as influenza, pneumococcus, human papillomavirus (HPV) and hepatitis B
• Must be willing and able to sign informed consent and follow all outlined procedures and recommendations in the protocol

You may not qualify if:

• History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease
• Any medical diagnosis placing the subject at high risk of surgical complications based on the transplant team's review of medical history.
• Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
• History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years.
• Human immunodeficiency virus, mycobacteria, hepatitis B (Hepatitis risk is for those with hepatitis B (HB) surface and/or core antigen and/or hepatitis B virus (HBV) DNA positive. Thos that are HB core antibody positive are at minimal risk and everyone else is not at risk), or hepatitis C.
• Presence of active documented systemic infection or recent systemic infection within the past three months
• Chemical and/or alcohol dependency or abuse
• Presence of low lying pelvic kidney(s). Pelvic and horse shoe kidneys are common in the Rokitansky syndrome, and occur with a frequency as high as 30-40%. These abnormalities are usually known to subjects as part of their Mullerian agenesis diagnosis. If the patient is unsure about the status of their kidneys, the performance of a renal ultrasound is considered standard of care. These patients need to be informed of any kidney abnormalities, as they are frequently associated with kidney stones or obstructive kidney disease.
• BMI greater than 30 kg/m2

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (4)

• Johannesson L, Humphries LA, Porrett PM, Testa G, Anderson S, Walter JR, Rush M, Ferrando CA, O'Neill K, Richards EG. Classification and treatment of vaginal strictures at the donor-recipient anastomosis after uterus transplant. Fertil Steril. 2024 Sep;122(3):525-534. doi: 10.1016/j.fertnstert.2024.04.019. Epub 2024 Apr 16.

  PMID: 38636770 DERIVED

• Walter JR, Johannesson L, Falcone T, Putnam JM, Testa G, Richards EG, O'Neill KE. In vitro fertilization practice in patients with absolute uterine factor undergoing uterus transplant in the United States. Fertil Steril. 2024 Sep;122(3):397-405. doi: 10.1016/j.fertnstert.2024.04.017. Epub 2024 Apr 15.

  PMID: 38631504 DERIVED

• Richards EG, Agatisa PK, Davis AC, Flyckt R, Mabel H, Falcone T, Tzakis A, Farrell RM. Framing the diagnosis and treatment of absolute uterine factor infertility: Insights from in-depth interviews with uterus transplant trial participants. AJOB Empir Bioeth. 2019 Jan-Mar;10(1):23-35. doi: 10.1080/23294515.2019.1572672. Epub 2019 Mar 11.

  PMID: 30855220 DERIVED

• Arian SE, Flyckt RL, Farrell RM, Falcone T, Tzakis AG. Characterizing women with interest in uterine transplant clinical trials in the United States: who seeks information on this experimental treatment? Am J Obstet Gynecol. 2017 Feb;216(2):190-191. doi: 10.1016/j.ajog.2016.11.1028. Epub 2016 Nov 16. No abstract available.

  PMID: 27865979 DERIVED

Study Officials

• Michelle Kuznicki, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 9, 2015
• Study Start: October 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)