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Trial record 87 of 102 for:    Valcyte

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

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ClinicalTrials.gov Identifier: NCT02409147
Recruitment Status : Suspended (Lack of funding)
First Posted : April 6, 2015
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Alexander Maskin, University of Nebraska

Brief Summary:
This study will explore the feasibility of initiating a uterine transplant program at UNMC. Using the procedural templates established by a successful Swedish team, the investigators will identify emotionally and socially stable females of reproductive age with intact ovaries who are unable to gestate a child due to congenital or acquired uterine factor infertility (UFI). Women will be 21 to 35 years of age upon entry into the protocol, with normal ovarian reserve and otherwise healthy for pregnancy. After careful screening, participants will undergo egg harvest, in-vitro fertilization, and embryo cryopreservation using standard methods. Women who successfully complete in vitro fertilization and cryopreservation of at least six embryos will be eligible to receive implantation of a deceased donor uterus. After a period of observation to ensure normal menstrual cycling and graft viability, embryo implantation will be undertaken. Gestations will be carefully monitored by our high-risk pregnancy specialists. Medical research interventions include uterine harvest from a deceased donor, surgical implantation of the organ utilizing standard transplant techniques, careful post-transplant follow-up including immune suppression therapy tailored to minimize fetal compromise, and careful management of pregnancy. After childbearing is complete (at most two gestations), the donor uterus will be removed. In addition, open-ended interviews and written surveys will be conducted to elicit ethical and psychosocial concerns arising from the experience of subjects and their families, health care providers, and the wider community. The investigators intent is to monitor outcomes lifelong for transplant recipients and live-born infants.

Condition or disease Intervention/treatment Phase
Uterus Transplant Procedure: Uterine Transplant Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initiation of a Deceased Donor Uterine Transplantation Program at the University of Nebraska Medical Center
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Arm Intervention/treatment
Experimental: Patients
Healthy female volunteers wishing to have a childbirth via uterine transplantation
Procedure: Uterine Transplant
Surgical implantation of a deceased donor uterus, induction therapy with thymoglobulin or basiliximab, maintenance immunosuppression with Prograf, Cellcept, and Prednisone. Anti-infective treatment with Bactrim and Valcyte and Nystatin. Anti-platelet therapy with aspirin. IVF per standard protocol. At time of birth: ceasarean section. Ultimately, transplant hysterectomy.
Other Names:
  • Thymoglobulin
  • Basiliximab
  • Prograf
  • Cellcept
  • Prednisone
  • Bactrim
  • Valcyte
  • Aspirin
  • Nystatin




Primary Outcome Measures :
  1. Successful Uterine Transplant [ Time Frame: 2 years ]
    A successful uterine transplant surgery will be obtained by deceased-donor graft implantation and take (without rejection) and successful menstruation for a set period. Once stability is achieved, IVF will be performed and close monitoring of a pregnancy will be done. Finally, a successful healthy baby will be delivered via C-section. A successful uterine transplant will accomplish all the previously described metrics



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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409147


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Alexander T Maskin, MD UNMC

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Responsible Party: Alexander Maskin, Assistant Professor of Surgery, University of Nebraska
ClinicalTrials.gov Identifier: NCT02409147     History of Changes
Other Study ID Numbers: 138-15-FB
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Valganciclovir
Death
Pathologic Processes
Aspirin
Mycophenolic Acid
Nystatin
Trimethoprim, Sulfamethoxazole Drug Combination
Prednisone
Thymoglobulin
Basiliximab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics