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CompletedNCT03590405GOT-BMC-UTxUpdated Dec 15, 2021

Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC

An interventional study of uterus transplantation surgery and IVF in Mrk Anomaly and Infertility, Female, sponsored by Sahlgrenska University Hospital. Completed at 2 sites in Sweden. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-15.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.

Read the detailed description

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery.

Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut

02

Conditions studied

  • Mrk Anomaly
  • Infertility, Female

Keywords

  • uterus
  • infertility
  • transplantation
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 2 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion criteria recipient

  • age \< 38 years
  • psychologicaly stable
  • BMI \< 35
  • no systemic disease
  • no standing medication
  • in a stable relationship or married
  • normal ovarian reserve
  • absolute uterine factor infertility
  • normal kidney function

Inclusion criteria donor

  • close relative to recipient
  • age \< 60 years
  • normal pregnancies
  • maximum two cesarean sections
  • BMI \< 35
  • no major systemic disease
  • no previous major surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    uterus transplantation

    uterus transplantation from living donor with the donor being close relative

    Procedure: uterus transplantation surgery and IVF

Interventions

  • Procedureuterus transplantation surgery and IVF

    IVF before surgery living donor uterus transplantation ET

06

What researchers measure

Primary outcomes

  1. live birth

    live birth

    Time frame: 3 years

07

Study locations

2 sites
  • Sahlgrenska University Hospital
    Gothenburg, 41345, Sweden
  • Mats Brännström
    Göteborg, SE-41345, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03590405
Lead sponsor
Sahlgrenska University Hospital
Collaborators
Saint Joseph University, at Bellevue Medical Centre
Responsible party
Mats Brännström (Professor, Sahlgrenska University Hospital) — Principal investigator
First posted
Jul 18, 2018
Start date
Jun 15, 2018
Primary completion
Dec 1, 2021
Completion
Dec 1, 2021
Last update
Dec 15, 2021

Study contacts

Mats Brännström, MD, PhD
principal investigator · Sahlgrenska University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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