Infertility, FemaleNCT03252795
Uterus Transplantation From a Multi-organ Donor
A study testing uterus transplantation in people with Infertility, Female and Mayer Rokitansky Kuster Hauser Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Female, Mayer Rokitansky Kuster Hauser Syndrome
- What is being tested?
- uterus transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Nov 2016to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- At least 8 frozen embryos after IVF/intracytoplasmic sperm injection [ICSI]
- Living in Belgium and a good health insurance
- Willing and able to provide informed consent
Who cannot join
- Major pelvic surgery
- Major chronic illnesses
- Other risk factors or malignancies
- BMI > 30
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital - Women's Clinic
Ghent, 9000
+3293322117, baarmoedertransplantatie@uzgent.be
About this study
Official title: Uterus Transplantation From a Multi-organ Donor: A Prospective Trial
Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.
- Being tested
- uterus transplantation
- Keywords
- Infertility, female, Mayer Rokitansky Kuster Hauser Syndrome, Transplantation; Deceased donor
- Medical subject headings
- Infertility, Female, Mullerian aplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterus transplantationProcedure or surgery
transplantation of a uterus from a deceased donor
| Study group | Role | What they receive |
|---|---|---|
| Uterus transplantation | Experimental | Not described Receives: Procedure: uterus transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the uterus 1 year after transplantation
Survival of the uterus 1 year after transplantation
Measured: 1 year after uterus transplantation
Complications after uterus transplantation
Complications after uterus transplantation
Measured: As long as the uterus remains in situ (the uterus will be removed within one year after delivery)
Ongoing pregnancy rate
Ongoing pregnancy rate
Measured: 4 weeks after embryo transfer
Take home baby rate
Take home baby rate
Measured: 9 months after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start3 Nov 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252795
- Sponsor's protocol ID
- EC/2016/0731
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2017
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterus Transplantation From a Multi-organ Donor: A Prospective Trial
- ClinicalTrials.gov ID
- NCT03252795
- Acronym / sponsor ID
- EC/2016/0731
- Keywords
- Infertility, female, Mayer Rokitansky Kuster Hauser Syndrome, Transplantation; Deceased donor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterus transplantation | Experimental | Procedure: uterus transplantation |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- Major pelvic surgery
- Major chronic illnesses
- Other risk factors or malignancies
- BMI > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uterus transplantationtransplantation of a uterus from a deceased donor | Procedure or surgery | Uterus transplantation |
Primary outcome
Survival of the uterus 1 year after transplantation
Time frame: 1 year after uterus transplantation
Survival of the uterus 1 year after 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)
Complications after uterus transplantation
Ongoing pregnancy rate
Time frame: 4 weeks after embryo transfer
Ongoing pregnancy rate
Take home baby rate
Time frame: 9 months after embryo transfer
Take home baby rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterus transplantation in people with Infertility, Female and Mayer Rokitansky Kuster Hauser Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Feb 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Weyers, MD, PhD (+3293325446, steven.weyers@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the uterus 1 year after transplantation (time frame: 1 year after uterus transplantation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2024.