Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II
- Conditions
- Infertility, Female
- Registration Number
- NCT02987023
- Lead Sponsor
- 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,
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 8
- age below 38 years
- absolute uterine factor infertility
- BMI<30
- systemic disease
- psychiatric disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Live births after uterus transplantation 5 years Assessed by records from birthing unit and Swedish National Birth registry
- Secondary Outcome Measures
Name Time Method Development of children after uterus transplantation 8 years Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV)
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden