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Uterine Transplantation for the Treatment of Uterine Factor Infertility

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02573415
First Posted: October 9, 2015
Last Update Posted: July 27, 2017
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.
Information provided by (Responsible Party):
The Cleveland Clinic
  Purpose

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 Intervention
Primary Uterine Infertility Procedure: Uterus Transplant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uterine Transplantation for the Treatment of Uterine Factor Infertility

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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:
  • 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

  • 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


Estimated Enrollment: 10
Study Start Date: October 2015
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Uterus Transplantation
Women will undergo deceased donor uterine transplantation after IVF.
Procedure: Uterus Transplant
transplant of a deceased donor uterus.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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


Locations
United States, Florida
Cleveland Clinic
Cleveland, Florida, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Rebecca Flyckt, MD The Cleveland Clinic
  More Information

Publications:

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02573415     History of Changes
Other Study ID Numbers: FLA 14-085
First Submitted: October 8, 2015
First Posted: October 9, 2015
Last Update Posted: July 27, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female