Acceptance of Uterus Transplantation

Resolve Infertility Clinical Trial

Official title:

Transplantation of an Uterus for Treatment of an Absolute Uterine Infertility

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03048396
• Other study ID #: 211/2016A
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 31, 2016
• Last updated: February 8, 2017
• Start date: October 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: University Women's Hospital Tübingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transplantation of an uterus

Description:

Uterus transplantation will be performed from live donors to patients with absolute uterine factor infertility. Organ procurement from the donor will be performed by laparotomy. Transplantation will also be performed by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• age below 40 years

• absolute uterine factor infertility

• BMI < 30

Exclusion Criteria:

• systemic disease

• psychiatric disease

Related Conditions & MeSH terms

• Infertility
• Resolve Infertility

Intervention

Procedure:
• Uterus transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Women's Hospital Tübingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who are interested in an uterus transplantation		3 years
Primary	Number of patients from these who do have a potential donor		3 years
Primary	Number of patients from these who do have a medical indication for an uterus transplantation		3 years