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NCT02987023 Clinical Trial

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

Infertility, Female Clinical Trial

— UTX-robot  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02987023
Other study ID # SahlgrenskaUTx
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2016
Est. completion date December 2021

Study information
Verified date December 2021
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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,

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 information / eligibility
Status Completed
Enrollment 8
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 38 Years
Eligibility Inclusion Criteria: - age below 38 years - absolute uterine factor infertility - BMI<30 Exclusion Criteria: - systemic disease - psychiatric disease

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• uterus transplantation
Uterus transplantation from live donor

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Live births after uterus transplantation Assessed by records from birthing unit and Swedish National Birth registry 5 years
Secondary Development of children after uterus transplantation Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV) 8 years
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