ive and deceased donor uterus transplantation as a treatment option for women with absolute uterine factor infertility

Not Applicable

Recruiting

• Conditions: Absolute uterine factor infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12622000917730
• Lead Sponsor: Dr Rebecca Deans

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-27
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

For recipient:
1.Diagnosed with AUFI and intact ovaries.
2.Childbearing age 18-42 years (must have embryos cryopreserved at <38 years of age).
3.A vaginal canal, measuring a minimum length of 7 cm, she can have vaginal dilator therapy during screening.
4.Non-smoker or abstinent for 6 months minimum
5.Body mass index less than or equal to 30
6.Willing to undergo in-vitro fertilization and medically cleared for in-vitro fertilization.
7.Women who wish to have a live donor transplant will be required to have a potential live donor.
8.Negative for the following sexually transmissible infections: Gonorrhoea, Chlamydia and Syphilis.
9.No active candida infection of the vagina.
10.History of Herpes (HSV-2) with no current symptoms. Subject may require preventative maintenance per study doctor discretion (anti-viral treatment).
11.Have 2 kidneys and a normal creatinine/eGFR level for their age

For living uterus (womb) donors
1.Blood type matching to the recipient permitting the donation
2.If aged < 55 years (or up to 60 years) the donor must be on hormone replacement therapy since menopause
3.You must not have had any previous cancers/malignancies
4.You must not be in poor health (i.e. you must not have diabetes, autoimmune diseases, cardiovascular disease, etc.)
5.You must have had no disease with an increased risk of thromboembolism (blood clots
6.Psychologically stable and must be prepared to undergo psychological testing
7.If the donor has a partner, he / she must be willing to participate in psychological testing
8.Non-smoker or abstinent for at least 5 years

For deceased uterus (womb) donors
1.Female
2.Aged < 55 years (or up to 60 years if on HRT if known)
3.Suitable as brain-dead multi-organ donor, and registered as multi-organ donor as per NSW Organ and Tissue Donation Service (OTDS)
4.Acceptance for donation of uterus from family or previously by donor
5.At least one normal pregnancy and childbirth
6.No systemic disease
7.No previous major surgery in the abdomen or on uterus
8.No previous hysterectomy
9.Non-smoker if known
10.BMI <35
11.No previous malignancy of the uterus or other organ or tissue

Exclusion Criteria

For recipient:
1.Subject with Diabetes Mellitus Type I and II
2.Subject has known hypersensitivity to drugs including: Tacrolimus, Thymoglobulin or CellCept.
3.Subject with existing hypertension, as per investigator’s discretion.
4.Subject who has a history of a bone marrow transplant.
5.Subject who has history of cancer in last five years.
6.Subject who has alcohol or drug abuse within 12 months of screening.
7.Subject with any pre-existing medical or psychological condition that would pose the subject at an increased risk, as per the investigator’s discretion.
8.Renal failure (abnormal creatinine / GFR)
9.Disease with an increased risk or personal history of thromboembolism

For living uterus (womb) donors
1.History of cancers in the past 5 years
2.Subject who has a history of a bone marrow transplant.
3.Systemic diseases (diabetes, autoimmune diseases, cardiovascular disease, etc.)
4.Disease with an increased risk or personal history of thromboembolism
5.Previous surgery for uterus or cervix cell changes
6.Positive HPV (16 or 18) or any cellular dysplasia of the cervix in the past 2 years
7.No previous major abdominal or uterine surgery
8.BMI >30
9.Cigarette smoker
10.Inability to consent to the risks of major morbidity and mortality

Study & Design

• Study Type: Interventional
• Study Design: Not specified