Uterine transplant for women with infertility due to absence of uterus

Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Factor Infertility

This study is testing if a uterine transplant from a donor can help women with no uterus due to infertility become pregnant and have a baby.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 20 Years to 65 Years
• Sex: Female
• Sponsor: Baylor College of Medicine (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05263076 on ClinicalTrials.gov

What this trial studies

This study aims to treat Absolute Uterine Factor Infertility (AUFI) through uterine transplantation using a uterus from either a living or deceased donor. It will involve 10 biologically female participants aged 20-40 who have at least one functioning ovary. The study will assess the physical, emotional, and mental readiness of candidates through consultations and various procedures before proceeding with the transplant. The ultimate goal is to achieve pregnancy and live birth following the transplantation.

Who should consider this trial

Good fit: Ideal candidates are women aged 20-40 diagnosed with Absolute Uterine Factor Infertility who have at least one functioning ovary.

Not a fit: Patients with active infections or those who do not meet the eligibility criteria, such as having no functioning ovaries, may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could provide a viable option for women with AUFI to conceive and carry their own children.

How similar studies have performed: Previous studies on uterine transplants have shown success, with live births reported following similar procedures, indicating a promising approach.

Eligibility criteria

RECIPIENT INCLUSION CRITERIA

1. Women who are diagnosed with Absolute Uterine Factor Infertility (AUFI) and who have at least one functioning ovary.
2. Women of childbearing age (20-40 years old) who are biologically female (XX karyotype).
3. Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
4. Subjects will have negative testing for Gonorrhea Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (Subjects with previously treated STDs will be included if the infection is no longer present and has no impact. If a subject develops an STD/infection pre-operatively, she will be treated and monitored for a period of 3 months until she is no longer affected. She will then become eligible for transplant. If a subject develops an STD/infection after transplant/during pregnancy she will be treated appropriately. Prior to the embryo transfer the patient will be tested and treated if necessary. Any patient with an active STD/infection will be ineligible for any elective procedure until she is tested and treated appropriately.)
5. Subjects who are HSV-2 negative or who have a history of HSV-2 with no current symptoms. Subjects may require preventative maintenance per study doctor discretion.
6. Subjects have received counseling regarding all fertility options and alternatives to uterine transplant such as adoption or surrogate pregnancy.
7. Subjects are willing to undergo in-vitro fertilization to obtain the necessary 4 viable embryos required for eligibility for transplant if they have not already banked 4 viable embryos.
8. Subjects have been evaluated by a fertility specialist and determined to have good ovarian reserve and reproductive potential.
9. Subjects must agree that in the event of withdrawal from the study while the transplanted uterus is in place, unless she is enrolled in an equivalent uterine transplant program, she will be required to undergo a hysterectomy for her own safety.
10. Subject meets psychological recipient criteria.
11. Subject must be willing to complete questionnaires about their infant's growth and development and return them to the study team.

RECIPIENT EXCLUSION CRITERIA

1. Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test.
2. Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or Everolimus.
3. Subject with a diagnosis of hypertension, or any other significant medical condition that makes this procedure unsafe or is a contraindication to surgery or anesthesia.
4. Subject who has a history of solid organ or bone marrow transplant, per investigator's discretion.
5. Subject who has a history of cancer, per investigator's discretion.
6. Subject with a body mass index \>30.
7. Subject with an active infection including candida and/or bacterial vaginosis.
8. Subject who is seropositive for HIV, HBV, HCV.
9. Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator.
10. Subject unwilling or unable to comply with study requirements.
11. Subject unable to undergo in-vitro fertilization or not cleared for transplant.
12. Subject who has smoked within the last 6 months.
13. Subject who has alcohol or drug abuse within 12 months of screening.
14. Subject with any pre-existing clinical or medical conditions that would put the subject at an increased risk. Of note, for Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome, the investigators will favor Type 1 variants as Type 2 is associated with skeletal/spinal and renal anomalies, making them higher risk candidates.

DONOR INCLUSION CRITERIA

1. Women must be between 25-65 years of age. If a subject is less than 40 years old she must be certain that she does not wish to carry more children, and she will attest to this decision.
2. Subjects will not have active human 142 papillomavirus (HPV) or active cervical dysplasia present.
3. Subjects will have negative testing for Gonorrhea, Chlamydia and Syphilis and will not have any active bacterial vaginosis or candida infection. (Subjects with previously treated STDs will be included if the infection is no longer present and has no impact. If a subject develops an STD/infection pre-operatively, she will be treated and monitored for a period of 3 months until she is no longer affected. Any patient with an active STD/infection will be ineligible for any elective procedure until she is tested and treated appropriately.)
4. Subjects who are HSV-2 negative, or have a history of HSV-2 but with no current symptoms. Subjects may require preventative maintenance per study doctor discretion.
5. Subjects will have a normal uterus on sonogram and CT.
6. Subjects will have normal psychological donor criteria (if living).
7. Subjects will have had at least one prior full term live birth.

DONOR EXCLUSION CRITERIA

1. Donor over the age of 65.
2. Body mass index \>30.
3. Subject with an active infection including candida and/or bacterial vaginosis.
4. Subject who is seropositive for HIV, HBV, HCV
5. Subject who has had cancer in the last five years.
6. Subject with any pre-existing clinical or medical condition that would place the subject at an increased risk or would be a contraindication to surgery or anesthesia.
7. Subject who has smoked within the last 6 months.
8. Subject who has alcohol or drug abuse within 12 months of screening.
9. Subject unwilling or unable to comply with study requirements.

Where this trial is running

Houston, Texas

• Texas Children's Hospital — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: John Goss, M.D. — Baylor College of Medicine
• Study coordinator: Transplant Services Coordinator

Conditions Mayer Rokitansky Kuster Hauser Syndrome; Absence of Uterus; Infertility of Uterine Origin; Uterine Transplant; AUFI; Absolute Uterine Factor Infertility; Infertility; MRKH