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Uterine Transplantation for the Treatment of Uterine Factor Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02573415
Recruitment Status : Enrolling by invitation
First Posted : October 9, 2015
Last Update Posted : April 13, 2023
Information provided by (Responsible Party):
Koji Hashimoto, The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Primary Uterine Infertility Procedure: Uterus Transplant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uterine Transplantation for the Treatment of Uterine Factor Infertility
Study Start Date : October 2015
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Uterus Transplantation
Women will undergo deceased donor uterine transplantation after IVF.
Procedure: Uterus Transplant
transplant of a deceased donor uterus.

Primary Outcome Measures :
  1. Number of successful live births after uterus transplant and IVF [ Time Frame: 2 years after transplantation ]
    Full term birth by cesarian section after IVF followed by uterus transplant

Secondary Outcome Measures :
  1. rate of pregnancy complications after IVF and uterus transplant [ Time Frame: 9 months after successful implantation of embryo ]

    The following complications will be monitored:

    1. Hypertension
    2. pre-eclampsia
    3. intrauterine growth restriction
    4. premature rupture of membranes
    5. preterm delivery
    6. intrauterine fetal demise

  2. rate of neonatal complications [ Time Frame: birth by cesarian section to discharge from hospital ]

    The following neonatal complications will be monitored:

    1. birth defects
    2. perinatal infections
    3. low birth weight
    4. neonatal death
    5. neonatal intensive care unit admissions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Must meet criteria for uterine factor infertility

    1. Prior hysterectomy
    2. Congenital absence or malformation of the uterus preventing pregnancy c, Infertility due to uterine damage from prior injury or infection
  2. 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)
  3. Must be willing to undergo a psychiatric and social work pre-transplant evaluation
  4. 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
  5. Must be willing and able to receive potent immunosuppressive medications and must be able to follow standard infection prophylaxis protocols
  6. Must be willing to receive standard vaccinations such as influenza, pneumococcus, human papillomavirus (HPV) and hepatitis B
  7. Must be willing and able to sign informed consent and follow all outlined procedures and recommendations in the protocol

Exclusion Criteria:

  1. History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease
  2. Any medical diagnosis placing the subject at high risk of surgical complications based on the transplant team's review of medical history.
  3. Current smoker (smoking cessation must have occurred 3 months prior to enrollment)
  4. History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years.
  5. 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.
  6. Presence of active documented systemic infection or recent systemic infection within the past three months
  7. Chemical and/or alcohol dependency or abuse
  8. 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.
  9. BMI greater than 30 kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573415

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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: Koji Hashimoto, MD, PhD The Cleveland Clinic
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Koji Hashimoto, Staff Physician, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02573415    
Other Study ID Numbers: FLA 14-085
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: April 13, 2023
Last Verified: April 2023
Additional relevant MeSH terms:
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Genital Diseases
Urogenital Diseases