Mullerian Anomaly of VaginaMULANNCT04732546
Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies (MULAN)
An observational study of Mullerian Anomaly of Vagina and Mullerian Anomaly of Uterus, Nec, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies. Read more about this study
- Who is it for?
- Ages Up to 45 years, women only
- Conditions the study is for
- Mullerian Anomaly of Vagina, Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Cervix
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2000to 31 Dec 2050
- Phase
- Observational
- 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 Up to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: diagnosed and/or treated in the Ghent University Hospital
Who may be able to join
- women with a uterus
- presence of a mullerian variation
- Maximum age 45y
Who cannot join
- women without a uterus
- aged >45y
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
UZ Ghent
Ghent, East Flanders, 9000
Eline Meireson, 093327817 ext. 0032, eline.meireson@uzgent.be
About this study
Official title: Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies: a Retrospective Cohort
The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.
Read the detailed description
Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women.
The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.
- Conditions
- Mullerian Anomaly of Vagina, Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Cervix
- Keywords
- Mullerian anomaly, Diagnostic tools, Surgical treatment, Reproductive function, Obstetric complications
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with a mullerian variation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility
Time to clinical pregnancy
Measured: 10 years after trying to conceive
Fertility
Early pregnancy loss
Measured: 18 weeks after conception
Surgical approach
Different surgical approaches used
Measured: during surgery
Surgical success
Relief of symptoms after surgery
Measured: 15 years after surgery
Secondary outcomes (2)
Diagnostic accuracy
The ability of a test to detect a Mullerian variation when it is present and detect the absence of a Mullerian variation when it is absent
Measured: at the time of diagnostic workup
Obstetric complications
Complications during pregnancy, labor, delivery, and the postpartum period
Measured: 1 year after conception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Jan 2000
- Primary completion31 Dec 2020
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mullerian Anomaly of VaginaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjalina Hamerlynck, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732546
- Sponsor's protocol ID
- B6702020000012
- Acronym
- MULAN
- Status last verified
- Dec 2023
- First submitted
- 26 Jan 2021
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies: a Retrospective Cohort
- ClinicalTrials.gov ID
- NCT04732546
- Acronym / sponsor ID
- MULAN / B6702020000012
- Conditions
- Mullerian Anomaly of Vagina, Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Cervix
- Keywords
- Mullerian anomaly, Diagnostic tools, Surgical treatment, Reproductive function, Obstetric complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 1 Feb 2021 (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.
The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.
Detailed description
Mullerian anomalies are rare, therefore they are not well known and not often considered as differential diagnosis. This causes a delay in the diagnosis with risk of long lasting symptoms and adverse effects on the reproductive function. However, the diagnosis can be made more accurately with improved diagnostic tools. Moreover, minimally invasive surgery allows for preservation and potential improvement of fertility in these women.
The purpose of this study is to get a better understanding of the clinical implications (including reproductive problems and obstetric complications), appropriate diagnostic tools and correct surgical treatment of Mullerian anomalies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a mullerian variation | – | – |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- diagnosed and/or treated in the Ghent University Hospital
Key inclusion criteria (3 listed)
- women with a uterus
- presence of a mullerian variation
- Maximum age 45y
Key exclusion criteria (2 listed)
- women without a uterus
- aged >45y
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
Fertility
Time frame: 10 years after trying to conceive
Time to clinical pregnancy
Fertility
Time frame: 18 weeks after conception
Early pregnancy loss
Surgical approach
Time frame: during surgery
Different surgical approaches used
Surgical success
Time frame: 15 years after surgery
Relief of symptoms after surgery
2 secondary outcomes
Diagnostic accuracy
Time frame: at the time of diagnostic workup
Obstetric complications
Time frame: 1 year after conception
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 22 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Diagnostic, Therapeutic and Reproductive Aspects of Patients With Mullerian Anomalies
Mullerian Anomaly of Uterus, Nec, Mullerian Anomaly of Vagina
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.
Tjalina Hamerlynck principal investigator
University Hospital, Ghent
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 Mullerian Anomaly of Vagina and Mullerian Anomaly of Uterus, Nec, 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 3 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: looking for participants now, as of the sponsor's last update on 22 Dec 2023. 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 Eline Meireson (093327817 ext. 0032, eline.meireson@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertility (time frame: 10 years after trying to conceive). 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 22 Dec 2023.