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Trial record 16 of 370 for:    genital diseases AND (woman OR women OR female) AND live birth

Uterine Transplant in Absolute Uterine Infertility (AUIF)

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ClinicalTrials.gov Identifier: NCT02741102
Recruitment Status : Not yet recruiting
First Posted : April 18, 2016
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Stefan G Tullius, Brigham and Women's Hospital

Brief Summary:
This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of follow-up is planned.

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

Detailed Description:

There are approximately 9.5 million women in the United States with Absolute Uterine Factor Infertility (AUFI).Congenital uterine infertility in women is linked to a malformed or absent mullerian system termed MRKH - Rokitansky's or Mayer-Rokitansky-Kuster-Hauser Syndrome). Additional causes of acquired uterine infertility include a hysterectomy subsequent to life-threatening hemorrhage during childbirth or as a consequence to a hysterectomy related to cervical cancer or for large symptomatic fibroids. Additional causes may include intrauterine adhesions subsequent to surgical abortion or infection.

Uterine transplantation will provide a much needed medical option for many women in the U.S. and overseas who are unable to carry their own children based on uterine infertility. Centers outside of the US have initiated uterus transplant programs. Initial attempts were reported from Saudi Arabia. While the deceased donor transplant had been successful, successful pregnancies were not achieved. Another deceased donor transplant had been performed in Turkey with a uterus procured from a deceased donor. Although several IVF attempts had been performed, they had not resulted in live births.

Uterus transplants from live donors have been successful. In October 2014, Swedish doctors treating a woman born without a uterus, announced the world's first live birth of a healthy baby boy after a live donor uterine transplantation. Since then, an additional three babies have been born in Sweden to mothers who received live donor uterus transplants. A fifth baby is at term and a 6th pregnancy has been reported.

For this study, the investigators plan to screen 30 patients in order to enroll 10 patients, 5 recipients and their respective donors. Prospective recipients will undergo comprehensive medical and psychological evaluation. If deemed an appropriate candidate, In Vitro Fertilization would be started with the goal of obtaining 6 normal embryos for implantation. The uterus of a suitable live donor would then transplanted into the recipient. The recipient would need to take potent anti-rejection drugs and undergo regular assessments for rejection. After one year, embryo transfer to the transplanted uterus would be tried. Up to 6 cycles would be attempted hopefully resulting in pregnancy. If pregnancy results, the recipient would be followed by the high risk pregnancy team. Delivery will be by Caesarian Section. A woman may have up to 2 pregnancies with the transplanted uterus. The uterus is later removed so the recipient no longer has to take anti-rejection drugs.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uterine Transplant in Absolute Uterine Infertility (AUIF)
Study Start Date : June 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Women with AUFI
Women with AUFI must meet criteria for uterine transplant. In vitro fertilization to obtain 6 (screened) healthy embryos for cryo-preservation precedes uterine transplant from an appropriate donor The recipient will be required to take potent anti rejection medications including Thymoglobulin, Prednisone, Tacrolimus, Mycophenolate Mofetil (MMF) , later substituted with Azathioprine to avoid birth defects. One year later, up to 6 attempts using 1 screened embryo at a time will be tried to achieve pregnancy. During pregnancy, the high risk pregnancy and transplant teams will follow the recipient. The goal is a full term baby and delivery will be by Caesarian section. A second pregnancy may be attempted. Afterward, the uterus will be explanted.
Procedure: Uterine Transplant
Treating Absolute Uterine Factor Infertility by Uterus Transplant. Potential recipients undergo IVF to obtain 6 embryos for cryopreservation followed by live donor uterine transplant. After 1 year, embryo transfer is done to achieve pregnancy. Delivery is by Caesarian section. The recipient may have up to 2 children by these methods and then the uterus is removed so that immunosuppression can be stopped.




Primary Outcome Measures :
  1. Number of successful live births following uterus transplant/embryo transfer [ Time Frame: 2 years after uterine transplant ]
    Full term live birth by caesarian section after uterus transplant and IVF


Secondary Outcome Measures :
  1. Rate of complications during pregnancy in uterus transplant recipient [ Time Frame: 9 months after pregnancy achieved by embryo transfer ]
    Monitoring for pre-eclampsia, hypertension, pre-term delivery

  2. Rate of complications following uterine donation [ Time Frame: Up to 2 years post donation ]
    Monitoring for excessive bleeding , infection and bladder dysfunction

  3. Impact of uterine donation on donor quality of life [ Time Frame: Up to 2 years post donation ]
    Measured by serial SF 36 QOL survey by psychiatrist at pre-donation and at follow-up appointments

  4. Cost comparison for uterine transplant vs. surrogacy vs adoption [ Time Frame: Up to 5 years after uterine transplant ]
    At the end of the study, investigators will calculate average cost of each modality, i.e. transplant vs surrogacy vs adoption to compare the three alternatives to infertility

  5. Impact of uterine transplant on quality of life [ Time Frame: Up to 5 years after uterine transplant ]
    Measured by serial SF 36 QOL survey by psychiatrist pre-transplant and at follow-up appointments..



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Uterine Transplant Inclusion/Exclusion Criteria

RECIPIENT:Inclusion Criteria

  • Age 18-40
  • Clinical evidence of AUFI (Absolute Uterine Factor Infertility)
  • Able to produce at least 6 normal embryos by IVF for future use
  • Reasonable weight with BMI (Body Mass Index) less than 30.
  • Normal kidney function
  • Able to undergo transplant and be compliant with treatment
  • Has stable partner and social supports
  • Partner willing to undergo psychological evaluation and receive immunizations as recommended
  • Stable home environment to support a child

Exclusion Criteria :

  • Active smoking, alcohol use or use of illicit drugs
  • Inability to comply with required treatment (taking pills, having biopsies, frequent appointments )
  • Having a condition that would make pregnancy or taking anti rejection medicines too risky.
  • Active infection: Human Immunodeficiency Virus (HIV) , Tuberculosis, Hepatitis B, Hepatitis C
  • History of extensive abdominal or pelvic surgery
  • History of abnormal Papanicolaou test (PAP smear) or genital warts
  • History of pelvic inflammatory disease

DONOR:Inclusion criteria

  • Age over 40 up to age 60
  • Has completed having a family
  • Previous pregnancies were carried to term (no miscarriages)
  • Able to take a birth control pill containing estrogen
  • Weight reasonable with BMI (Body Mass Index) of 30 or less
  • Good social supports

Exclusion Criteria:

  • Active smoking, alcohol use or use of illicit drugs
  • Psychiatric illness
  • Cervical or endometrial polyps (growths) or tumors in the uterus muscle
  • History of more than 1 Caesarean section
  • History of abnormal PAP smear or genital warts
  • Internal scarring from extensive abdominal or pelvic surgery
  • Hypertension, Coronary artery disease, Chronic Obstructive Lung disease (emphysema) and Diabetes
  • Active cancer or incompletely treated cancer
  • Active infection including Human Immunodeficiency Disease (HIV) , Tuberculosis, Hepatitis B or Hepatitis C
  • Significant history of either blood clots or bleeding tendencies
  • Evidence of coercion or exchange of money or goods for donating the organ

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): NCT02741102


Contacts
Contact: Stefan G Tullius, M.D. 617-732-6866 stullius@partners.org

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Stefan G Tullius, M.D. Brigham and Womens Hospital

Publications of Results:
Other Publications:
Christensen, M, Kronberg, CJ, Knudsen UB: Pre-eclampsia and arterial stiffness - a 10 year follow-up of previous pre-eclamptic women. Pregnancy Hyprtens 2015; 5: 72-73.
Nair, A, et al: Ann NY Acad Sci 2008; 1127:83-91, Brannstroem, M, et al.: Experimental uterus transplantation. Hum Reprod Update 2010; 16:329-345).

Responsible Party: Stefan G Tullius, Chief , Division of Transplant Surgery, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02741102     History of Changes
Other Study ID Numbers: 2015P002552
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Stefan G Tullius, Brigham and Women's Hospital:
Infertility
AUFI

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female