Uterine Allotransplantations Using Uterine Grafts From Brain-dead Female Donors

NCT02637674 | Suspended DMC

• 1 other identifier: I14002/ATU
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

Uterus transplantation may enable women with uterine factor infertility to become pregnant and give birth. This study will explore the feasibility of a uterine transplant and eight subjects will undergo deceased donor uterine transplantation at CHU de Limoges. There phases involved in this study: Primary, Secondary and Tertiary Screening, Medical Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up.

Conditions

Infertility

Keywords

allotransplantation

Outcome Measures

Primary Outcomes (1)

• Successful uterus transplant

  Success will be measured by by the occurrence of at least two spontaneous menstrual cycles during the first year following the UT.

  12 month after each transplantation

Secondary Outcomes (4)

• UT complications

  up to 41 after transplantation

• Successful of pregnancies achieved

  up to 30 months after transplantation

• Pregnancy complications after UT

  up to 39 months after transplantation

• Successful of births achieved

  up to 39 months after transplantation

Study Arms (1)

Uterus Transplantation

EXPERIMENTAL

Women will undergo deceased donor uterine transplantation after IVF

Procedure: Uterus Transplant

Interventions

Uterus Transplant PROCEDURE

Uterus Transplantation

Eligibility Criteria

• Age: 25 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Recipients :
• Primary selection criteria
• Patients with uterine factor infertility defined as followed :
• A history of hysterectomy for benign pathology or postpartum haemorrhage
• Total or partial uterine agenesis
• Age ≥ 25 and \< 35 years
• couple living together for at least two years
• BMI ≤ 30 kg/m2
• At least 12 months from colpoplasty surgery
• At least 12 months from diagnosis of uterine infertility
• Nulliparous
• Compliance with the legal criteria of medically assisted procreation Acceptance to take part of NEHAVI cohort
• Acceptance of the protocol constraints
• Coverage by the French national Health service
• Secondary selection criteria

You may not qualify if:

• Recipients Primary criteria for non-selection
• Previous major abdomino-pelvic surgery
• Previous ileal or sigmoid colpoplasty
• History of cancer
• Active tobacco consumption
• Hypertension (HT), including treated HT
• Type 1 or 2 diabetes
• Chronic kidney disease
• Evolving cardiovascular pathology
• Psychiatric disease
• Under guardianship or conservatorship
• Contraindication to one of the treatments used in the study
• Contraindication to ovarian stimulation treatment except uterine infertility
• Secondary criteria for non-selection
• Prior psychological evaluation contraindicating participation in the study

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (4)

Service de gynécologie

Limoges, 87000, France

Location

Service de néphrologie

Limoges, 87000, France

Location

Service de Pharmacologie

Limoges, 87000, France

Location

Service de réanimation

Limoges, 87000, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Tristan GAUTHIER, Doctor

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 22, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

FR (4)