Uterine Allotransplantations Using Uterine Grafts From Brain-dead Female Donors

Launched by UNIVERSITY HOSPITAL, LIMOGES · Dec 18, 2015

Keywords

ClinConnect Summary

It is estimated that 1 in 500 women of reproductive age have congenital or acquired uterine factor infertility (UFI).

The solution for such patients who wish to have a child is either to adopt or use a surrogate. The latter is illegal in France .Uterine transplantation (UT) could be a beneficial medical alternative.

Over the last 13 years, about 30 experimental studies have been conducted on rodents, rabbits, pigs, sheeps and monkeys. They have shown TU to be feasible, with a number of births achieved after uterus auto-transplantation, syngeneic transplantation and allotransplantation. Ho...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 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
• • Signed informed consent by the patient and spouse
• • Prior psychological evaluation not contraindicating participation in the study
• • Normal ovarian function and satisfactory ovarian reserve
• • Compliance with primary selection criteria.
• • Tertiary selection criteria
• • At least 10 embryos obtained by IVF
• • Compliance with primary and secondary selection criteria
• • Donors
• • • Brain dead female ≥ 18 years old and ≤ 50 years old.
• Exclusion Criteria:
• • 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
• • Rare blood group AB or B, for the purpose of reducing the waiting time for a graft. Groups A and O combined constitute over 85% of donors (see appendix)
• • Positive irregular agglutinin test (IAT)
• • Ovarian insufficiency according to laboratory norms
• • Presence of anti-HLA antibodies
• • Negative Epstein-Barr virus serology
• • HIV or hepatitis C infection,
• • Hepatitis B (acute, chronic, treated)
• • Presence of a single kidney
• • Detected cardiac pathology
• • Contraindication to participation into the trial detected at the anaesthetic assessment
• • Dermatological, stomatological and/or ear, nose, and throat (ENT) pathology/ies contraindicating treatment with ISDs
• • Thoracic-abdominal-pelvic CT scan anomalies contraindicating UT and the use of treatment with ISDs
• • Increased risk of miscarriage (thrombophilia, anormal karyotype)
• • Separation of the couple.
• • Tertiary criteria for non-selection
• • Spouse/partner with azoospermia
• • Less than 10 frozen embryos obtained
• • Separation of the couple.
• • Previous uterine transplantation
• • Donors
• • Length of no flow \> 10 min
• • Pregnancy at the time of brain death
• • Time from delivery \< 3 months
• • Positive oncogen human papillomavirus (HPV )test (16 and 18)
• • Myomas \> 3 cm and/or endoluminal fibroid and/or endometrial polyps and/or heterogenous annexial cyst seen in a pelvic ultrasound or CT scan
• • Multi-scarred uterus ( ≥ 2 uterine scars)
• • Registered in the national registry of persons who refuse to donate any organ.
• • Opposition to the uterine retrieval from the donor's relatives.
• • Uterine agenesis and uterine malformation
• • Criteria usually seen as contraindicating retrieval (HIV+, evolutive neoplasia, etc.)