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

NCT02987023 | Completed DMC

• 1 other identifier: SahlgrenskaUTx
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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,

Conditions

Infertility, Female

Keywords

infertility, uterus, transplantation

Outcome Measures

Primary Outcomes (1)

• Live births after uterus transplantation

  Assessed by records from birthing unit and Swedish National Birth registry

  5 years

Secondary Outcomes (1)

• Development of children after uterus transplantation

  8 years

Interventions

uterus transplantation PROCEDURE

Uterus transplantation from live donor

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

absolute uterine factor infertile women \> 38 years

You may qualify if:

• age below 38 years
• absolute uterine factor infertility
• BMI\<30

You may not qualify if:

• systemic disease
• psychiatric disease

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (5)

• Dahm-Kahler P, Kvarnstrom N, Brannstrom M. Robotic live donor hysterectomy. Curr Opin Organ Transplant. 2021 Dec 1;26(6):640-645. doi: 10.1097/MOT.0000000000000926.

  PMID: 34593704 BACKGROUND

• Brannstrom M, Kvarnstrom N, Groth K, Akouri R, Wiman L, Enskog A, Dahm-Kahler P. Evolution of surgical steps in robotics-assisted donor surgery for uterus transplantation: results of the eight cases in the Swedish trial. Fertil Steril. 2020 Nov;114(5):1097-1107. doi: 10.1016/j.fertnstert.2020.05.027. Epub 2020 Aug 19.

  PMID: 32828495 BACKGROUND

• Brannstrom M, Dahm-Kahler P, Ekberg J, Akouri R, Groth K, Enskog A, Broecker V, Molne J, Ayoubi JM, Kvarnstrom N. Outcome of Recipient Surgery and 6-Month Follow-Up of the Swedish Live Donor Robotic Uterus Transplantation Trial. J Clin Med. 2020 Jul 22;9(8):2338. doi: 10.3390/jcm9082338.

  PMID: 32707899 BACKGROUND

• Wentz E, Hagberg B, Hagberg H, Bokstrom H, Brannstrom M. Uterus transplantation; first data on neurologic, neuropsychiatric, and physical examination follow-up of children up to 6 years of age. Hum Reprod. 2025 Dec 1;40(12):2419-2429. doi: 10.1093/humrep/deaf178.

  PMID: 40971624 DERIVED

• Brannstrom M, Dahm-Kahler P, Kvarnstrom N, Enskog A, Olofsson JI, Olausson M, Molne J, Akouri R, Jarvholm S, Nilsson L, Stigson L, Hagberg H, Bokstrom H. Reproductive, obstetric, and long-term health outcome after uterus transplantation: results of the first clinical trial. Fertil Steril. 2022 Sep;118(3):576-585. doi: 10.1016/j.fertnstert.2022.05.017. Epub 2022 Jun 11.

  PMID: 35697530 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, endometrial tissue, cervical tissue, placental tissue

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mats Brännström, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)