Transplantation of Uterus for Uterine infertiLIty From Living Donor or Deceased Donor

Launched by RENNES UNIVERSITY HOSPITAL · Feb 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the possibility of uterus transplantation for women who cannot become pregnant due to a missing or unsuitable uterus, a condition known as Uterine Factor Infertility (UFI). The goal is to help these women achieve their dream of parenthood through a transplant from either a living or deceased donor. To qualify for the trial, participants need to be between 18 and 40 years old, have a body mass index (BMI) of 30 or less, and must have been informed about other options like adoption. They should also have a plan for having children, whether with a partner or on their own.

If a woman is selected for the trial, she can expect a thorough screening process to ensure compatibility with the donor and to assess her overall health. The trial is currently recruiting participants, and it aims to provide a hopeful avenue for women facing infertility due to uterine issues. It’s important to note that both living and deceased donors can be involved, and the trial is being conducted at the University Hospital of Rennes, where medical teams are experienced in this area of research.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria for UT recipient:
• • Patient aged 18 to 40 at the time of the UT;
• • BMI (Body Mass Index) ≤ 30 kg/m²;
• • With AUFI (type 1 or 2 MRKH syndrome and hysterectomy);
• • Informed about the possibility of adoption;
• • Compatibility with the donor (ABO group, Human Leukocyte Antigen (HLA) typing);
• • Up-to-date vaccinations;
• • Able to reach the transplant center in less than 11 hours (applicable only for the "deceased donor" arm);
• • Having a parental project that is formulated by a heterosexual couple, by a couple of women or by a single woman;
• • Vaginal cup of length greater than or equal to 7 cm.
• Inclusion Criteria for a deceased brain-dead uterus donor:
• • Any person who is brain dead and who has been duly diagnosed with the following criteria: Female gender;Age ≤ 42 years;Compatibility with the recipient (ABO group, HLA typing).
• Inclusion Criteria for a live uterus donor:
• • Patient belonging to the family of the recipient (mother, sister, aunt, mother-in-law...) or any person who can prove a stable emotional relationship for more than 2 years with the recipient (paragraphs 1 and 2 of Article L.1231-1 of the Public Health Code);
• • Age ≥ 37 years and ≤ 62 years ;
• • BMI ≤ 30 kg/m²;
• • Having completed all her parenthood plans and no longer having any plans of pregnancy;
• • Having had at least one live-born child at term (i.e. after 37 weeks of of amenorrhea);
• • Compatibility with the recipient (ABO group, HLA typing);
• • Normal suprapubic and/or endovaginal ultrasound or pelvic Magnetic Resonance Imaging (MRI), including uterine (no uterine abnormalities);
• • Satisfactory uterine vessels assessed by MRI angio.
• Exclusion Criteria for UT recipient:
• • Patient with acquired uterine infertility and having had one or more children;
• • Non-stable psychological state defined by a clinical psychologist after a qualitative interview;
• • Severe co-morbidity;
• • Association of severe abnormality with MRKH syndrome other than renal such as a cardiac malformation;
• • A single pelvic kidney (urinary malformation that can be associated with MRKH syndrome);
• • Pathogenic parental genetic anomaly which may lead to medical termination of pregnancy in the current state of knowledge;
• • Diabetes (HbA1c \> 6%);
• • Disorders of hemostasis: Prothrombin rate \<70%;
• • Hemoglobin abnormality;
• • Existence of hypertension;
• • Vaginal reconstruction (neovagina) by digestive segment (colonic plastic surgery or other);
• • History of major abdominal or pelvic surgery;
• • Known thrombophilia (acquired or constitutional);
• • HIV (Human Immunodeficiency Virus), HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), HAV (Hepatitis A Virus), HTLV (Human T-Lymphotropic Virus) serology positive and presence of irreversible communicable infectious diseases;
• • Positive vaginal hPV-HR (human Papilloma Virus High Risk) test;
• • Signs of chronic renal disease;
• • Drug addiction or alcoholism not weaned for more than 2 years or drug addiction or excessive alcohol consumption (\> 30 g/day of alcohol) current;
• • History of cancer less than 10 years old, cancer under treatment (except in the cancer in situ, or basal cell skin lesion) or diagnosed during the selection process;
• • History of pelvic radiotherapy or vaginal brachytherapy regardless of when this irradiation was performed;
• • Known psychiatric pathology;
• • Active tuberculosis (i.e. under treatment);
• • Known or suspected contraindications to one or more of the treatments (active substance or excipient(s)) to be administered for the purposes of the study and/or essential treatment having an interaction/impact with one of the treatments planned by the research;
• • Existence of organ dysfunction not compatible with the uterine transplantation protocol;
• • History of smoking (defined as consumption greater than 20 packs/year) not weaned for more than 2 years or active smoker.
• Exclusion Criteria for a deceased brain-dead uterus donor:
• • Initial circulatory arrest of more than 10 minutes;
• • Opposition to organ donation (register of refusals) or to uterine removal by a relative of the deceased;
• • Chronic and uncontrolled hypertension;
• • Absence of uterus (history of hysterectomy or uterine agenesis);
• • Presence of uterine pathology;
• • Delivery less than 6 months ago or ongoing pregnancy;
• • History of several caesarean sections (multi-scarred uterus: more than 2);
• • History of major abdominal or pelvic surgery;
• • Infection of the sepsis type or uncontrolled infection (bacterial, viral viral, parasitic fungal, active Chagas disease);
• • Encephalitis of viral origin or febrile of uncertain origin or meningoencephalitis of unknown origin;
• • Risk of Prion disease transmission;
• • Presence of an infectious disease: HIV, HCV, HBV, HTLV and presence of irreversible communicable infectious diseases;
• • Carrying of human Papilloma Virus High Risk (hPV-HR) class 1 positive in the genital tract if known before transplantation;
• • Positive EBV (Epstein-Barr Virus) serology in the donor if the recipient is EBV negative for EBV ;
• • Positive pre-transplant virtual crossmatch;
• • Donor/recipient ABO final check in the operating room before transplantation positive;
• • Drug addiction or alcoholism not weaned for more than 2 years or drug addiction or excessive alcohol consumption (\> 30 g/day of alcohol) current;
• • History of cancer less than 5 years old, cancer under treatment (except in the cancer in situ, or basal cell skin lesion) ;
• • Active tuberculosis (i.e. under treatment);
• • History of smoking (defined as consumption greater than 20 packs/year) not weaned for more than 2 years or active smoker.
• Exclusion Criteria for a live uterus donor:
• • Non-stable psychological state defined by a clinical psychologist clinician after a qualitative interview;
• • Severe co-morbidity;
• • Diabetes (HbA1c \> 6%);
• • Hemostasis disorders: Prothrombin rate \<70%;
• • Hemoglobin abnormality;
• • hypertension treated with more than 2 antihypertensive drugs;
• • Delivery less than 6 months ago or ongoing pregnancy;
• • History of cervical pathology;
• • History of recurrent miscarriage syndrome (defined as 3 consecutive consecutive miscarriages);
• • History of premature delivery before 36 weeks of amenorrhea;
• • History of pre-eclampsia;
• • History of caesarean sections;
• • History of major uterine surgery;
• • History of major abdominal or pelvic surgery;
• • Endometrial biopsy and diagnostic hysteroscopy showing an abnormality of the endometrium;
• • Known thrombophilia (acquired or constitutional);
• • HIV, HCV, HBV, HTLV serology positive and presence of irreversible communicable infectious diseases;
• • Positive vaginal hPV-HR (human Papilloma Virus High Risk) test;
• • PCR (Polymerase Chain reaction) on HSV (Herpes Simplex Virus) 1/2 positive sample;
• • Abnormal vaginal swab;
• • Signs of chronic kidney disease;
• • Risks of Prion disease transmission;
• • Drug addiction or alcoholism not weaned for more than 2 years or drug addiction or excessive alcohol consumption (\> 30 g/day of alcohol) current;
• • History of cancer less than 10 years old, cancer under treatment (except in the cancer in situ, or basal cell skin lesion) or diagnosed during the selection process;
• • History of pelvic radiotherapy or vaginal brachytherapy regardless of when this irradiation was performed;
• • Known psychiatric pathology;
• • Active tuberculosis (i.e. under treatment);
• • Presence of a known thromboembolic risk factor;
• • Angio-MRI, CT angiography and/or arteriography revealing an anomaly incompatible with uterine transplantation;
• • History of smoking (defined as consumption greater than 20 packs/year) not weaned for more than 2 years or active smoker.