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

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Completed
• CT.gov ID: NCT02987023
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Duration (Months): 61
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 8 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Dec 1, 2021

Outcome Measures

Primary Outcome Measures

1. Live births after uterus transplantation [5 years]

   Assessed by records from birthing unit and Swedish National Birth registry

Secondary Outcome Measures

1. Development of children after uterus transplantation [8 years]

   Assessed by growth parameters and neuropsychiatric tests (Bayley Mental Scale, M-CHAT, CBCL, WPPSI-IV)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age below 38 years

• absolute uterine factor infertility

• BMI<30

Exclusion Criteria:

• systemic disease

• psychiatric disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Gothenburg		Sweden	41345

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden

Investigators

• Principal Investigator: Mats Brännström, MD, PhD, Göteborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mats Brännström, Professor, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT02987023
• Other Study ID Numbers: SahlgrenskaUTx
• First Posted: Dec 8, 2016
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mats Brännström, Professor, Sahlgrenska University Hospital, Sweden: infertility, uterus, transplantation
• Additional relevant MeSH terms: Infertility; Infertility, Female

Study Results

No Results Posted as of Dec 15, 2021