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Trial record 24 of 399 for:    Recruiting, Not yet recruiting, Available Studies | "Infertility"

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

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ClinicalTrials.gov Identifier: NCT02656550
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
This study aims to investigate the treatment of absolute uterine infertility (AUI) due to congenital or surgical absence of a uterus or presence of a nonfunctioning uterus. The investigators will follow a model based on a Swedish study to enroll 10 women with functioning ovaries and successfully transplant the uterus from either a living or cadaveric donor, with the goal of live birth after transplantation.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Factor Infertility
Actual Study Start Date : November 11, 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Uterine Transplant
Women will undergo uterine transplantation after IVF. Donor uterus will be from either a living donor or cadaveric.
Procedure: Uterine Transplant
Transplant of a uterus from either a living donor or a deceased donor.,
Other Names:
  • Thymoglobulin
  • Mycophenolate




Primary Outcome Measures :
  1. Number of successful live births after uterine transplant and IVF. [ Time Frame: 2 years after transplant ]
    Full term birth by cesarean section.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women diagnosed with Absolute Uterine Infertility (AUI) and intact native ovaries.
  2. Women of childbearing age 20-35.
  3. Human papillomarvius negative or received vaccination for human papillomarvius virus (HPV). Subjects with a history of HPV in the past must show a negative history since and test negative at screening.
  4. A subject who is negative for Gonorrhea, Chlamydia and Syphilis.
  5. A subject with the history of Herpes (HSV-2) with no current symptoms. Subject may require preventative maintenance per study doctor discretion.
  6. Subjects have received counseling regarding infertility alternatives to uterine transplant such as adoption or surrogate pregnancy.
  7. Willing to undergo in-vitro fertilization and medically cleared for in-vitro fertilization.
  8. Evaluated by a fertility specialist and determined to have good ovarian reproductive potential and ability to carry fetus to term.
  9. Must have the ability to fund, either through third party coverage or through other their own personal financing, any expenses associated with assisted reproduction services provided to them.
  10. Meets physiological recipient criteria

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 CellCept.
  3. Subject with existing hypertension, per investigator's discretion.
  4. Subject who has a history of solid organ or bone marrow transplant.
  5. Subject who has history of cancer in last five years.
  6. Subject with a body mass index >30.
  7. Subject with an active infection.
  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 12 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 pose the subject at an increased risk, as per the investigator's discretion.

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): NCT02656550


Contacts
Contact: Giuliano Testa, MD 214-880-2050 Giuliano.Testa@BSWHealth.org
Contact: Kristin P Wallis, BSN, RNC-OB 214-818-7703 kristin.wallis@BSWHealth.org

Locations
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Giuliano Testa, MD FACS MBA    214-820-2050    Giuliano.Testa@BSWHealth.org   
Contact: Wallis P Kristin, BSN, RNC-OB    214-818-7703    Kristin.Wallis@BSWHealth.org   
Sponsors and Collaborators
Baylor Research Institute

Publications:
Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02656550     History of Changes
Other Study ID Numbers: 015-158
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Baylor Research Institute:
Uterine Transplant
AUI
Rokitansky Syndrome

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Thymoglobulin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents