Uterine Transplantation for the Treatment of Uterine Factor Infertility

Status: Enrolling_by_invitation
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cleveland Clinic
Cleveland
Time Frame
Start Date: 2015-10
Completion Date: 2025-10
Participants
Target number of participants: 10
Treatments
Experimental: Uterus Transplantation
Women will undergo deceased donor uterine transplantation after IVF.
Related Therapeutic Areas
Sponsors
Leads: The Cleveland Clinic

This content was sourced from clinicaltrials.gov

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