Mayer-Rokitansky-Kuster SyndromeINSITUNCT04244409
INvestigational Study Into Transplantation of the Uterus
An observational study of Mayer-Rokitansky-Kuster Syndrome and Asherson's Syndrome, run by Womb Transplant UK at 1 site in United Kingdom.
Trial summary
Observational study on cohort of 10 women undergoing uterine transplantation using deceased donors Read more about this study
- Who is it for?
- Ages 24 to 38 years, women only
- Conditions the study is for
- Mayer-Rokitansky-Kuster Syndrome, Asherson's Syndrome, Postpartum Hemorrhage
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Feb 2019to 18 Feb 2024
- Phase
- Observational
- 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 24 to 38 years
- Women only
- Adult
Study population: Women with absolute uterine factor infertility
Who may be able to join
- Female
- Age - 24-38 (or 40 if eggs frozen <38)
- AUFI
- Normal length vagina
- No renal pathology
- BMI <30kg/m2
Show all 11Show fewer
- ASA grade I
- Meet psychological criteria
- Meet HFEA criteria for IVF
- Eligible for NHS treatment
- Speak fluent English
Who cannot join
- Unsuccessful oocyte retrieval (<10 good quality embryos)
- Previous multiple/significant surgeries
- Severe endometriosis
- Cancer patients <5 years in remission
- Previous living childbirth, adopted child or child born through surrogacy
- HIV or Hepatitis B / C positive
- Skin or intestinal neovagina
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Hospital, Imperial College NHS Trust
London, W12 0HS
Benjamin Jones, MRCOG, 02033131000, benjamin.jones@nhs.net
About this study
Observational study on cohort of 10 women undergoing uterine transplantation using deceased donors
- Conditions
- Mayer-Rokitansky-Kuster Syndrome, Asherson's Syndrome, Postpartum Hemorrhage, Cervical Cancer
- Keywords
- Gynaecology, Immunosuppression, In-vitro Fertilisation, Infertility, MRKH, Pregnancy, Transplantation, Uterus
- Medical subject headings
- Mullerian aplasia, Postpartum Hemorrhage, Uterine Cervical Neoplasms, Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: 5 years
Secondary outcomes (2)
Pregnancy rate
Measured: 5 years
Transplant success rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start18 Feb 2019
- Primary completion18 Feb 2022 (estimated)
- Study completion18 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mayer-Rokitansky-Kuster SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Womb Transplant UK
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Imperial College Healthcare NHS Trust
- Responsible party
- Principal investigator, Ben Jones, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244409
- Sponsor's protocol ID
- WombTransplantUK
- Acronym
- INSITU
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INvestigational Study Into Transplantation of the Uterus
- ClinicalTrials.gov ID
- NCT04244409
- Acronym / sponsor ID
- INSITU / WombTransplantUK
- Conditions
- Mayer-Rokitansky-Kuster Syndrome, Asherson's Syndrome, Postpartum Hemorrhage, Cervical Cancer
- Keywords
- Gynaecology, Immunosuppression, In-vitro Fertilisation, Infertility, MRKH, Pregnancy, Transplantation, Uterus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Womb Transplant UKUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust, Imperial College Healthcare NHS Trust
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 18 Feb 2022 (estimated)
- Study completion
- 18 Feb 2024 (estimated)
- First posted
- 28 Jan 2020 (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.
Observational study on cohort of 10 women undergoing uterine transplantation using deceased donors
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 38 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with absolute uterine factor infertility
Key inclusion criteria (11 listed)
- Female
- Age - 24-38 (or 40 if eggs frozen <38)
- AUFI
- BMI <30kg/m2
- ASA grade I
Key exclusion criteria (7 listed)
- Unsuccessful oocyte retrieval (<10 good quality embryos)
- Previous multiple/significant surgeries
- Severe endometriosis
- Cancer patients <5 years in remission
- Previous living childbirth, adopted child or child born through surrogacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Live birth rate
Time frame: 5 years
2 secondary outcomes
Pregnancy rate
Time frame: 5 years
Transplant success rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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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. This study is not recruiting at the moment.
Hammersmith Hospital, Imperial College NHS Trust
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mayer-Rokitansky-Kuster Syndrome and Asherson's Syndrome, run by Womb Transplant UK at 1 site in United Kingdom.
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 11 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Jan 2020. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 5 years). 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 28 Jan 2020.