ClinicalTrials.gg
RecruitingNCT03252795Updated Feb 14, 2024

Uterus Transplantation From a Multi-organ Donor

An interventional study of uterus transplantation in Infertility, Female and Mayer Rokitansky Kuster Hauser Syndrome, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2024-02-14.

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

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Nov 2016, registered Jun 2017).
  • Started Nov 2016; still recruiting 10 years later.

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Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 38 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Infertility, Female with a site in Belgium — 1 open to participants now, 3 under way, none of them phase 3. Infertility, Female · Belgium.

Planned enrollment
11th of 13
20 · median 134
Started
2016
with 1 other
No phase
3 of 16
1 open now
Registered
7th of 16
by date
Lead sponsor
1 of 16
University Hospital, Ghent

Among the 16 studies in Infertility, Female with a site in Belgium, this one is the 11th largest by planned enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2016, is one of 3 with no phase, and was the 7th registered.

Infertility, Female

552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.

Browse Infertility, Female studies →

Open to participants now

1 of the 16 studies in Infertility, Female with a site in Belgium is open now.

A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →

Who these studies take

Of the 91 Infertility, Female studies recruiting now, 10 (11%) set no upper age limit and 81 (89%) stop at 75 or younger; 9 take children under 18; 30 take healthy volunteers.

This study: 18 Years to 38 Years · female · no healthy volunteers.

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02

Study summary

Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.

03

Conditions studied

  • Infertility, Female
  • Mayer Rokitansky Kuster Hauser Syndrome

Keywords

  • Infertility, female
  • Mayer Rokitansky Kuster Hauser Syndrome
  • Transplantation; Deceased donor
04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female with Maier-Rokitansky-Kuster-Hauser syndrome
  • Mucosal neovagina of at least 7 cm
  • In a stable relationship for at least 1 year
  • Child wish
  • Good renal function (and presence of both kidneys)
  • Psychologically stable and compliant
  • At least 8 frozen embryos after IVF/intracytoplasmic sperm injection [ICSI]
  • Living in Belgium and a good health insurance
  • Willing and able to provide

Exclusion criteria

Exclusion Criteria:

  • Major pelvic surgery
  • Major chronic illnesses
  • Other risk factors or
  • > 30
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

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

Study arms

  • Experimental
    Uterus transplantation

    Procedure: uterus transplantation

Interventions

  • Procedureuterus transplantation

    transplantation of a uterus from a deceased donor

06

What researchers measure

Primary outcomes

  1. Survival of the uterus 1 year after transplantation

    Survival of the uterus 1 year after transplantation

    Time frame: 1 year after uterus transplantation

  2. Complications after uterus transplantation

    Complications after uterus transplantation

    Time frame: As long as the uterus remains in situ (the uterus will be removed within one year after delivery)

  3. Ongoing pregnancy rate

    Ongoing pregnancy rate

    Time frame: 4 weeks after embryo transfer

  4. Take home baby rate

    Take home baby rate

    Time frame: 9 months after embryo transfer

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2016 (actual). Primary completion is estimated for Dec 2027, 133 months after the start.

Of 141 non-industry interventional studies with no phase under Infertility, Female, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 133 months is above that.

Counting every sponsor, half of 155 studies reached it within 23 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 22, 2017
First posted
Aug 17, 2017
StartActual
Nov 3, 2016
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Feb 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03252795
Responsible party
Sponsor
First posted
Aug 17, 2017
Start date
Nov 3, 2016
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Feb 14, 2024

Study contacts

Steven Weyers, MD, PhD
Contact
steven.weyers@uzgent.be
+3293325446
Sara Somers, MSc
Contact
Sara.Somers@uzgent.be
+3293323757

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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