Uterus Transplantation From Deceased Donor - Gothenburg III

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03581019
• Collaborator: (none)
• Enrollment: 8
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 89.5
• Patients Per Site: 4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Deceased donor uterus transplantation will be offered to patients that have either been excluded from Gothenburg II because of donor criteria or because of early graft failure in Gothenburg I and II

Condition or Disease	Intervention/Treatment	Phase
Absolute Uterine Factor Infertility; Transplantation; Mrk Anomaly	Procedure: uterus transplantation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Observational studyObservational study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Uterus Transplantation From Deceased Donor - Gothenburg III
• Actual Study Start Date: Jun 17, 2018
• Anticipated Primary Completion Date: Dec 1, 2025
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Uterus transplantation Uterus transplantation	Procedure: uterus transplantation; uterus transplantation from deceased donor

Outcome Measures

Primary Outcome Measures

1. birth of healthy child [1-5 years after transplantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion criteria recipient

• initially included with IVF and excluded by donor issues of Gothenburg I or II

• initially included and excluded by early graft failure of Gothenburg I or II

• age < 40 years

• no systemic disease

• no standing medication

• satisfactory ovarian reserve

• BMI <35 and at BMI 30-35 waist circumference of < 82 cm

• absolute uterine factor infertility

• psychological stable

Inclusion criteria donor

• brain death and suitable as multiorgan donor

• acceptance for donation of uterus from family or previously by patient

• age <55 years

• at least one normal pregnancy and childbirth

• no previos malignancy

• no systemic disease

• no previous major surgery inn abdomen or on uterus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Gothenburg		Sweden	41345
2	Mats Brännström	Göteborg		Sweden	SE-41345

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden

Investigators

• Principal Investigator: Mats Brännström, 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: NCT03581019
• Other Study ID Numbers: Sahlgrenska-DD-UTx
• First Posted: Jul 10, 2018
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mats Brännström, Professor, Sahlgrenska University Hospital, Sweden: infertility, uterus, transplantation, MRKH
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Dec 15, 2021