Clinical Trial: Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II

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,

Detailed 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.
Sponsor: Sahlgrenska University Hospital, Sweden

Current Primary Outcome: Live births after uterus transplantation [ Time Frame: 5 years ]

Assessed by records from birthing unit and Swedish National Birth registry


Original Primary Outcome: Same as current

Current Secondary Outcome: 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)


Original Secondary Outcome: Same as current

Information By: Sahlgrenska University Hospital, Sweden

Dates:
Date Received: November 29, 2016
Date Started: November 2016
Date Completion: December 2022
Last Updated: December 5, 2016
Last Verified: December 2016