Is a uterine transplant a safe and effective option for women who do not have a uterus (for various reasons) to achieve pregnancy and gain parenthood.

Phase 1

Recruiting

• Conditions: Women with absolute uterine factor infertility (AUFI); Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12619000808145
• Lead Sponsor: Sydney Local Health district

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-03
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

a. The prospective donor must be between 40-65 years of age
b. The prospective donor must have a normal uterus on ultrasound and CT;
c. The prospective donor must meet psychosocial criteria;
d. The prospective donor must have had at least one prior live birth (gestation > 34-weeks).
1. Inclusion Criteria Recipient
a. Prospective recipient must be diagnosed with AUFI and have at least one functioning ovary;
b. Prospective recipient must be of childbearing age 18 – 45;
c. Prospective recipient must have received counselling regarding alternatives to UT such as adoption or surrogate pregnancy;
d. Prospective recipient must be willing to undergo in-vitro fertilization;
e. Prospective recipient must have been evaluated by a fertility specialist and determined to have good ovarian reproductive potential or are prepared to use donor oocytes;
f. Prospective recipient must meet psychosocial criteria;
g. Prospective recipient must be willing to complete questionnaires about their infant’s growth and development and return them to the study team.

Exclusion Criteria

a. Prospective donor over the age of 65;
b. Body mass index >30;
c. There should be no history of significant uterine or cervical surgery;
d. History of cigarette smoking in the past 3-months;
e. Prospective donor with active human 142 papillomavirus (HPV) or active cervical dysplasia;
f. Prospective Donor with untreated Gonorrhoea, Chlamydia or Syphilis;
g. In prospective donors who are positive for HSV-2 the prospective recipient will require additional counselling; the prospective donor should receive preventative therapy in order to prevent a flare in the peri-operative phase; the prospective recipient may also require preventative therapy;
h. Prospective donor with an active infection;
i. Prospective donor who is seropositive for HIV;
j. In prospective donors who are seropositive for HBV or HCV the prospective recipient will require additional counselling;
k. Prospective donor who has had cancer in last five years;
l. Prospective donor with any pre-existing clinical or medical conditions that would pose the donor at an increased risk, as per the investigator’s discretion;
m. Prospective donor unwilling or unable to comply with study requirements.
2. Exclusion Criteria for recipients
a. Prospective recipient who has active human 142 papillomavirus (HPV);
b. Prospective recipient with untreated Gonorrhoea, Chlamydia or Syphilis;
c. In prospective recipients who are positive for HSV-2 the prospective recipient will require additional counselling; the prospective recipient may also require preventative therapy;
d. Prospective recipient with Diabetes Mellitus Type I or II;
e. Prospective recipient with a known hypersensitivity to immunosuppressive medications;
f. Prospective recipient with existing hypertension, per investigator’s discretion;
g. Prospective recipient who has a history of solid organ or bone marrow transplant, per investigator’s discretion;
h. Prospective recipient who has a history of cancer, per investigator’s discretion;
i. Prospective recipient with a body mass index >30;
j. Prospective recipient with an active infection;
k. Prospective recipient who is seropositive for HIV;
l. In a prospective recipient who is seropositive for HBV or HCV the prospective recipient will require additional counselling and possible treatment;
m. Prospective recipient with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator;
n. Prospective recipient unwilling or unable to comply with study requirements;
o. Prospective recipient unable to undergo in-vitro fertilization;
p. Prospective recipient who has smoked within the last 3 months, per investigator’s discretion;
q. Prospective recipient who has alcohol or drug abuse within 12 months of screening;
r. Prospective recipient with any pre-existing clinical or medical conditions that would pose the subject at an increased risk, as per the investigator’s discretion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcomes: <br>-Successful transplantation of a human uterus with achievement of menstrual cycles<br>International standards suggest menstrual cycles normally return between 6-12 weeks post transplant. We will be constantly reviewing our patients (post-transplant) every 2 weeks for the first month, than every 4 weeks until pregnancy. Each review will include a physical and gynaecological exam and will be recorded in the patients medical record. <br>[After transplant is successfully performed the recipient will go on immunosuppressive agents to prevent graft rejection. Primary outcome time point will be up to 12 weeks post surgery. ]