Uterus Transplantation Procedure From a Live Donor

Not Applicable

Recruiting

• Conditions: Sterility, Female; Rokitansky Kuster Hauser Syndrome
• Interventions: Procedure: Uterus transplantation

• Registration Number: NCT04314869
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

Absolut uterine factor, meaning the absence of uterus, represents a cause for sterility without the possibility of a present treatment. The uterine factor affects millions of women and may be due to congenital problems, such as the Muller anomalies (Mayer Rockitansky Syndrome) or acquired by previous hysterectomy or intrauterine adhesions (Asherman's Syndrome). The uterine transplant would represent the only possibility for patients with an absolute uterine factor to achieve both genetic and gestational maternity.

Detailed Description

To obtain by laparoscopy a viable uterus for transplantation from a living donor is feasible. The laparoscopic procedure increases safety and provides the benefits of minimally invasive surgery to the grafting technique already described by laparotomy. The objective of the present study is to develop a pilot program in the transplant of a living donor. We include 5 pairs of uterine donor-transplant recipients indicated for sterility by absolute uterine factor due to Mayer Rokitansky Syndrome. Patients will undergo surgery for this transplant and after 6 months of it with correct function of the graft, embryos will be transferred in order to achieve pregnancy. C-section will be performed for delivery. The attempt of two gestations (if there are sufficient cryopreserved embryos for a second gestation) and withdrawing the graft (hysterectomy) and, therefore, immunosuppression is agreed.

Study Timeline

• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2020-05-23
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-07
• Last Update Posted: 2020-11-10
• Primary Completion: 2022-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recipient	Uterus transplantation	Patient with absolut uterine factor will undergo uterus transplantation.

Primary Outcome Measures

Name	Time	Method
Number of grafts obtained by laparoscopy	2 years	It is feasible to obtain the graft by laparoscopy

Secondary Outcome Measures

Name	Time	Method
Number of healthy newborns	5 years	A healthy newborn after C-section

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain