Initiation of a Deceased Donor Uterine Transplantation Program at the University of Nebraska Medical Center

• Register: ClinicalTrials.gov
• Last refreshed on: 21 August 2023
• Main ID: NCT02409147
• Date of registration: 27/03/2015
• Prospective Registration: Yes
• Primary sponsor: University of Nebraska
• Public title: Initiation of a Deceased Donor Uterine Transplantation Program at the University of Nebraska Medical Center
• Scientific title: Initiation of a Deceased Donor Uterine Transplantation Program at the University of Nebraska Medical Center
• Date of first enrolment: January 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/ct2/show/NCT02409147
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Alexander T Maskin, MD
• Affiliation: UNMC

Key inclusion & exclusion criteria

Inclusion Criteria:

- For transplantation, the criteria are as follows:

1. Female of reproductive age with intact native ovaries and no medical
contraindication to transplantation, including surgical procedure and subsequent
immunosuppression, and no medical contraindication to reproduction and gestation
in a transplanted uterus. Evaluation for a medical contraindication will be
determined by a maternal-fetal medicine specialist at UNMC.

2. Diagnosed with either congenital or acquired uterine factor infertility (UFI) and
counseled about alternate options for family building including gestational
surrogacy and/or adoption and provided access to these alternate services.
Acquired circumstances may include nonfunctional uterus and hysterectomy due to
benign disease (uterine fibroids, Asherman's syndrome, pelvic infection,
postpartum hemorrhage) or gynecologic malignancy of the uterus or cervix.
Additionally, UFI may be a result of congenital anomaly of the uterus and uterine
agenesis.

3. If uterine removal was for uterine or cervical cancer a minimum 5 year
recurrence-free time period will be required.

4. If MRKH Syndrome (Mayer-Rokitansky-Kuster-Hauser) or Mullerian agenesis is
present, the patient has a negative evaluation for other relevant congenital
abnormalities (such as a pelvic kidney). Additionally, women with Mulllerian
agenesis who have absence of the vagina must have had neovaginal creation surgery
prior to uterine transplant in order to allow for embryo transplantation and
monitoring of the organ after transplant.

5. Ovaries are intact with adequate ovarian reserve as determined by accepted
markers including anti-Mullerian hormone level (AMH), astral follicle count
and/or early follicular follicle stimulating hormone (FSH) levels.

6. Desires a biological child and is unable or unwilling to consider gestational
surrogacy, and / or seeks uterine transplantation as a means to experience
gestation, with an understanding of the limitations provided by the uterine
transplant in this respect.

7. Meets psychological evaluation criteria, e.g.,stable, committed relationship with
an individual who supports uterine transplant and intends to co-parent;
emotionally mature with good coping skills and no significantly adverse mental
health history; normal intellect allowing careful analysis of risks and benefits;
no evidence of coercion; no significant evidence of previous noncompliance with
medical care; no evidence of frank unsuitability for motherhood (e.g., previous
conviction for child abuse).

8. Likely to comply with medical management, including antirejection immune
suppression, frequent follow-up with surgical team, time-sensitive reproductive
endocrinology management, high-risk pregnancy management, possible high-risk
neonatal management.

9. Likely to be able to accommodate potential adverse outcomes such as loss of
graft, inability to conceive, loss of pregnancy, adverse fetal or neonatal
outcome.

10. Willing to consider transplant hysterectomy or termination of pregnancy if
medically necessary.

11. Willing to undergo oocyte harvest and in-vitro fertilization prior to
transplantation, with at least six viable embryos cryopreserved in anticipation
of post-transplant implantation.

12. Financially able to cover anticipated expenses of assisted reproductive services,
either through third party coverage or through personal assets.

Exclusion Criteria:

- For transplantation: Exclusions include genetic males, and women who do not meet the
inclusionary criteria above. Residence in the greater Omaha area during the
implantation and pregnancy period is required because of the time-sensitive nature of
transplantation and assisted reproductive technology, as well as the frequent medical
monitoring which will be required of transplant subjects.



Age minimum: 21 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Uterus Transplant

Intervention(s)

Procedure: Uterine Transplant

Primary Outcome(s)

Successful Uterine Transplant [Time Frame: 2 years]

Secondary ID(s)

0138-15-FB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors