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Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II (UTX-robot)

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ClinicalTrials.gov Identifier: NCT02987023
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Mats Brännström, Sahlgrenska University Hospital, Sweden

Brief Summary:
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy,

Condition or disease Intervention/treatment
Infertility, Female Procedure: uterus transplantation

Detailed Description:
The study is a follow up of NCT01844362. Uterus transplantation will be performed from live donors to patients with uterine factor infertility. If will be performed before transplantation. Organ procurement from the donor will be performed by robotic assisted laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months after transplantation. After birth of 1-3 children the uterus will be removed by hysterectomy.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Years
Official Title: Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II
Study Start Date : November 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: uterus transplantation
    Uterus transplantation from live donor


Primary Outcome Measures :
  1. Live births after uterus transplantation [ Time Frame: 5 years ]
    Assessed by records from birthing unit and Swedish National Birth registry


Secondary Outcome Measures :
  1. Development of children after uterus transplantation [ Time Frame: 8 years ]
    Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV)


Biospecimen Retention:   Samples With DNA
blood, endometrial tissue, cervical tissue, placental tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
absolute uterine factor infertile women > 38 years
Criteria

Inclusion Criteria:

  • age below 38 years
  • absolute uterine factor infertility
  • BMI<30

Exclusion Criteria:

  • systemic disease
  • psychiatric disease

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): NCT02987023


Contacts
Contact: Mats Brännström, MD, PhD +46736254455 mats.brannstrom@obgyn.gu.se
Contact: Pernilla Dahm-Kähler, MD, PhD +46739416493 pernilla.dahm.kahler@vgregion.se

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Mats Brännström, MD, PhD Göteborg University

Responsible Party: Mats Brännström, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02987023     History of Changes
Other Study ID Numbers: SahlgrenskaUTx
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be shared.

Keywords provided by Mats Brännström, Sahlgrenska University Hospital, Sweden:
infertility, uterus, transplantation

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