AzTrials
AzTrials

Primary Uterine InfertilityutxNCT01844362

Uterus Transplantation From Live Donor

A study testing uterine transplantation in people with Primary Uterine Infertility, run by Sahlgrenska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for
Primary Uterine Infertility
What is being tested?
uterine transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteSweden
Study dates
Sep 2012to 1 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • less than 39 years
  • good general health

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Mats Brännström

    Gothenburg, SE-41345

Other trials in Sweden

About this study

Official title: Prospective Case Series of Human Uterus Transplantation From Live Donor

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.

Read the detailed description

The study is ongoing, with inclusion of 9 patients.

Being tested
uterine transplantation
Keywords
uterus, transplantation, infertility
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • uterine transplantationProcedure or surgery

    Transplantation of the uterus from live donor and IVF treatment.

Study groups in NCT01844362
Study groupRoleWhat they receive
Uterine transplantationExperimentalPatients undergo transplantation of the uterus from live donor.
Receives: Procedure: uterine transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. surviving transplants (12 months)

    Measured: up to 3 years after transplantation

Secondary outcomes (1)

  1. pregnancy rate

    Measured: up to 3 years after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionApr 2018
  4. Study completion1 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01844362
Sponsor's protocol ID
utx-ld
Acronym
utx
Status last verified
Jun 2024
First submitted
23 Apr 2013
Last updated
24 Jun 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Scientific publications

Publications

  • 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.

    PubMed 37995381

  • 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.

    PubMed 34865019

  • 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.

    PubMed 32709381

  • 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.

    PubMed 32619006

  • 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.

    PubMed 31241745

  • 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.

    PubMed 37745947

  • 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.

    PubMed 34907538

  • 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.

    PubMed 32659865

  • 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.

    PubMed 27868389

  • 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.

    PubMed 27125227

  • 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.

    PubMed 25439846

  • 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.

    PubMed 25301505

  • 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.

    PubMed 24582522

  • 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.

    PubMed 26231464

  • 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.

    PubMed 26073658

Questions about this trial

What is this clinical trial studying?

A study testing uterine transplantation in people with Primary Uterine Infertility, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

surviving transplants (12 months) (time frame: up to 3 years after transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01844362, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.

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