NCT01844362

Brief Summary

Uterus transplantation, as a possible future treatment for uterine factor infertility, has been developed in animal species during the last decade. The study protocol includes transplantation of the uterus from a live donor (mother, relative, friend) into women with absolute uterine factor infertility (lack of uterus from birth or due to life saving hysterectomy).The recipient will be treated by standard immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted when at least 12 months have passed from transplantation. Approval for a case series including up to 10 patients has been acquired.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

5.6 years

First QC Date

April 23, 2013

Last Update Submit

June 21, 2024

Conditions

Primary Uterine Infertility

Keywords

uterustransplantationinfertility

Outcome Measures

Primary Outcomes (1)

  • surviving transplants (12 months)

    up to 3 years after transplantation

Secondary Outcomes (1)

  • pregnancy rate

    up to 3 years after transplantation

Other Outcomes (1)

  • live birth rate

    up to 4 years after transplantation

Study Arms (1)

Uterine transplantation

EXPERIMENTAL

Patients undergo transplantation of the uterus from live donor.

Procedure: uterine transplantation

Interventions

uterine transplantationPROCEDURE

Transplantation of the uterus from live donor and IVF treatment.

Uterine transplantation

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • less than 39 years
  • good general health

You may not qualify if:

  • poor ovarian resaerve or older than 39 years
  • systemic or psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mats Brännström

Gothenburg, SE-41345, Sweden

Location

Related Publications (20)

  • Jarvholm S, Kattstrom A, Kvarnstrom N, Dahm-Kahler P, Brannstrom M. Long-term health-related quality-of-life and psychosocial outcomes after uterus transplantation: a 5-year follow-up of donors and recipients. Hum Reprod. 2024 Feb 1;39(2):374-381. doi: 10.1093/humrep/dead245.

    PMID: 37995381BACKGROUND

  • Jarvholm S, Bokstrom H, Enskog A, Hammarling C, Dahm-Kahler P, Brannstrom M. Striving for motherhood after uterus transplantation: a qualitative study concerning pregnancy attempts, and the first years of parenthood after transplantation. Hum Reprod. 2022 Jan 28;37(2):274-283. doi: 10.1093/humrep/deab260.

    PMID: 34865019BACKGROUND

  • Jarvholm S, Dahm-Kahler P, Kvarnstrom N, Brannstrom M. Psychosocial outcomes of uterine transplant recipients and partners up to 3 years after transplantation: results from the Swedish trial. Fertil Steril. 2020 Aug;114(2):407-415. doi: 10.1016/j.fertnstert.2020.03.043. Epub 2020 Jul 22.

    PMID: 32709381BACKGROUND

  • Jarvholm S, Enskog A, Hammarling C, Dahm-Kahler P, Brannstrom M. Uterus transplantation: joys and frustrations of becoming a 'complete' woman-a qualitative study regarding self-image in the 5-year period after transplantation. Hum Reprod. 2020 Aug 1;35(8):1855-1863. doi: 10.1093/humrep/deaa143.

    PMID: 32619006BACKGROUND

  • Jarvholm S, Kvarnstrom N, Dahm-Kahler P, Brannstrom M. Donors' health-related quality-of-life and psychosocial outcomes 3 years after uterus donation for transplantation. Hum Reprod. 2019 Jul 8;34(7):1270-1277. doi: 10.1093/humrep/dez087.

    PMID: 31241745BACKGROUND

  • Broecker V, Brannstrom M, Bosmuller H, Sticova E, Maluskova J, Chiesa-Vottero A, Molne J. Reproducibility of Rejection Grading in Uterus Transplantation: A Multicenter Study. Transplant Direct. 2023 Sep 20;9(10):e1535. doi: 10.1097/TXD.0000000000001535. eCollection 2023 Oct.

    PMID: 37745947BACKGROUND

  • Karlsson CC, Dahm-Kahler P, Kvarnstrom N, Molne J, Broecker V, Brannstrom M. Hysterectomy after uterus transplantation and detailed analyses of graft failures. Acta Obstet Gynecol Scand. 2022 Mar;101(3):355-363. doi: 10.1111/aogs.14304. Epub 2021 Dec 14.

    PMID: 34907538BACKGROUND

  • Broecker V, Brannstrom M, Ekberg J, Dahm-Kahler P, Molne J. Uterus transplantation: Histological findings in explants at elective hysterectomy. Am J Transplant. 2021 Feb;21(2):798-808. doi: 10.1111/ajt.16213. Epub 2020 Aug 11.

    PMID: 32659865BACKGROUND

  • Molne J, Broecker V, Ekberg J, Nilsson O, Dahm-Kahler P, Brannstrom M. Monitoring of Human Uterus Transplantation With Cervical Biopsies: A Provisional Scoring System for Rejection. Am J Transplant. 2017 Jun;17(6):1628-1636. doi: 10.1111/ajt.14135. Epub 2017 Jan 3.

    PMID: 27868389BACKGROUND

  • Brannstrom M, Bokstrom H, Dahm-Kahler P, Diaz-Garcia C, Ekberg J, Enskog A, Hagberg H, Johannesson L, Kvarnstrom N, Molne J, Olausson M, Olofsson JI, Rodriguez-Wallberg K. One uterus bridging three generations: first live birth after mother-to-daughter uterus transplantation. Fertil Steril. 2016 Aug;106(2):261-6. doi: 10.1016/j.fertnstert.2016.04.001. Epub 2016 Apr 25.

    PMID: 27125227RESULT

  • Johannesson L, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Diaz-Garcia C, Olausson M, Brannstrom M. Uterus transplantation trial: 1-year outcome. Fertil Steril. 2015 Jan;103(1):199-204. doi: 10.1016/j.fertnstert.2014.09.024. Epub 2014 Oct 22.

    PMID: 25439846RESULT

  • Brannstrom M, Johannesson L, Bokstrom H, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Milenkovic M, Ekberg J, Diaz-Garcia C, Gabel M, Hanafy A, Hagberg H, Olausson M, Nilsson L. Livebirth after uterus transplantation. Lancet. 2015 Feb 14;385(9968):607-616. doi: 10.1016/S0140-6736(14)61728-1. Epub 2014 Oct 6.

    PMID: 25301505RESULT

  • Brannstrom M, Johannesson L, Dahm-Kahler P, Enskog A, Molne J, Kvarnstrom N, Diaz-Garcia C, Hanafy A, Lundmark C, Marcickiewicz J, Gabel M, Groth K, Akouri R, Eklind S, Holgersson J, Tzakis A, Olausson M. First clinical uterus transplantation trial: a six-month report. Fertil Steril. 2014 May;101(5):1228-36. doi: 10.1016/j.fertnstert.2014.02.024. Epub 2014 Feb 27.

    PMID: 24582522RESULT

  • Jarvholm S, Johannesson L, Clarke A, Brannstrom M. Uterus transplantation trial: Psychological evaluation of recipients and partners during the post-transplantation year. Fertil Steril. 2015 Oct;104(4):1010-1015. doi: 10.1016/j.fertnstert.2015.06.038. Epub 2015 Jul 28.

    PMID: 26231464RESULT

  • Jarvholm S, Johannesson L, Brannstrom M. Psychological aspects in pre-transplantation assessments of patients prior to entering the first uterus transplantation trial. Acta Obstet Gynecol Scand. 2015 Oct;94(10):1035-8. doi: 10.1111/aogs.12696. Epub 2015 Jun 30.

    PMID: 26073658RESULT

  • 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: 35697530RESULT

  • 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: 40971624DERIVED

  • Brannstrom M, Ekberg J, Sandman L, Davidson T. The costs per live birth after uterus transplantation: results of the Swedish live donor trial. Hum Reprod. 2025 Feb 1;40(2):310-318. doi: 10.1093/humrep/deae272.

    PMID: 39675045DERIVED

  • Carbonnel M, Petit M, Tarantino N, Morin V, Corneau A, Tourne M, Gueguan J, Molne J, Akouri R, Broecker V, Vinit A, Racowsky C, Brannstrom M, Ayoubi JM, Vieillard V. Analysis of Immunological Biomarkers Associated With Rejection After Uterus Transplantation in Human. Transplantation. 2025 Feb 1;109(2):e119-e133. doi: 10.1097/TP.0000000000005126. Epub 2024 Jul 18.

    PMID: 39020469DERIVED

  • Davidson T, Ekberg J, Sandman L, Brannstrom M. The costs of human uterus transplantation: a study based on the nine cases of the initial Swedish live donor trial. Hum Reprod. 2021 Jan 25;36(2):358-366. doi: 10.1093/humrep/deaa301.

    PMID: 33247912DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mats Brännström, MD, PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2013

First Posted

May 1, 2013

Study Start

September 1, 2012

Primary Completion

April 1, 2018

Study Completion

December 1, 2021

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Scientific publications

Locations

SE(1)