Mrkh SyndromeMOQANCT07186764
Evaluation of the Quality of Life and Gynecological Follow-up of Patients Treated for Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome
An observational study of Mrkh Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome affects 1 in 4,500 women and consists of utero-vaginal aplasia in 46 chromosom XX women, most often diagnosed in the presence of primary amenorrhea. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mrkh Syndrome
- What is being tested?
- Questionnaires and Semi-directed interview
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2026to 1 Sep 2027
- How long will I take part?
- 1 Day
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with Mayer-Rokitansky-Küster-Hauser syndrome and patients followed in gynecological consultation without the presence of this syndrome
Who may be able to join
- For Mayer-Rokitansky-Küster-Hauser patients:
- Patient over 18 and under 50
- Confirmed diagnosis of Mayer-Rokitansky-Küster-Hauser syndrome
- Diagnosis announced more than 1 year ago
- Patient treated by the CRMR PGR
- Patient affiliated with or benefiting from a social security scheme
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- Fluency in French
- For the control population:
- Patient over 18 and under 50
- Patient affiliated with or benefiting from a social security scheme
- Fluency in French
Who cannot join
- For Mayer-Rokitansky-Küster-Hauser patients:
- Minors over 50 years of age
- Recent diagnosis < 1 year
- Other causes of uterine or vaginal aplasia, surgical or congenital
- Patients benefiting from a legal protection measure (guardianship, curatorship, legal protection)
- Patients unable to understand or answer the questionnaires
Show all 10Show fewer
- For the control population:
- Minors over 50 years of age
- Patients benefiting from a legal protection measure (guardianship, curatorship, legal protection)
- Patients unable to understand or answer the questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Endocrino-gynéco-pédiatrie, Hôpital des Enfants, 330 Avenue de Grande Bretagne
Toulouse, 31059
Emeline Muller, 05 61 77 87 07 ext. +33, muller.E@chu-toulouse.fr
About this study
Official title: Evaluation of the Overall Quality of Life and Gynecological Follow-up of Patients Treated for Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome at the Toulouse University Hospital
Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome affects 1 in 4,500 women and consists of utero-vaginal aplasia in 46 chromosom XX women, most often diagnosed in the presence of primary amenorrhea. This diagnosis, occurring in adolescence during the period of identity formation, can have significant psychological repercussions. This malformation can alter the body image and personal relationships of affected patients, beyond the impact on their sexual lives. Management around the disclosure is a crucial moment for these patients. Individual or group psychological support is systematically offered.
Several international studies show that these patients experience a decline in their quality of life, and they are more anxious and depressed. Participation in support groups improves this state.
The objective of this study is therefore to better understand Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome and the issues patients may face. For this reason, it seems essential to us to evaluate the overall quality of life, the quality of sexual life, the psychological state and the gynecological follow-up of women before or after treatment for vaginal aplasia.
Read the detailed description
Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome affects 1 in 4,500 women. In its classic form, it consists of uterovaginal aplasia in 46XX chromosom women, most often diagnosed in the presence of primary amenorrhea. This diagnosis, occurring in adolescence during the period of identity formation, can have significant psychological repercussions. Indeed, this uterovaginal aplasia is responsible for the inability to achieve vaginal penetration during sexual intercourse, the absence of menstruation, and the inability to conceive.
It is therefore easy to understand that this malformation can alter the body image and personal relationships of affected patients, beyond the impact on their sexual lives. Management around the time of disclosure is a crucial moment for these patients. Individual or group psychological support is systematically offered.
Before the 2010s, surgical techniques for vaginal creation were widely proposed, which was rejected in uterine transplant research protocols. Since 2014 (the first uterine transplant), expert physicians working with the Rare Gynecological Pathology Reference Centers have offered patients who wish to undergo vaginal self-dilation (the Frank technique). This neovagina allows for sexual intercourse with vaginal penetration. It is also an essential prerequisite in uterine transplant protocols, the criterion for which is a vaginal depth greater than 7 cm.
This condition requires a multidisciplinary approach. The discovery of this malformation raises many questions, due to the significant social, legal, and ethical implications: What do these patients think of their overall quality of life and their sexual quality? Do they have more psychological disorders than the general population? Are they well-monitored gynecologically? Does the treatment of utero-vaginal aplasia improve patients' quality of life? Several international studies show that these patients experience a decline in their quality of life; they are more anxious and more depressed. Participation in support groups improves this condition. These are older studies with cohorts of patients who most often benefited from surgical treatment, which is no longer the standard method today. These studies therefore do not allow an assessment of the current population.
The objective of this study is therefore to better understand Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome and the issues patients may face. To this end, we believe it is essential to assess the overall quality of life, sexual quality, psychological state, and gynecological follow-up of women before or after treatment for vaginal aplasia. Indeed, women must be able to fully experience their sexuality and achieve fulfillment through it. The impact of proposed medical treatments on sexuality must therefore be a concern for practitioners.
The evaluation of functional outcomes and the potential impact of our treatments must therefore be an integral part of follow-up.
Currently, there is little data regarding long-term outcomes after medical or surgical treatment.
The objective is to identify areas for improvement which could bring to the management and follow-up of this syndrome, in order to subsequently offer a personalized care pathway and better meet the needs of patients.
- Conditions
- Mrkh Syndrome
- Being tested
- Questionnaires, Semi-directed interview
- Keywords
- MRKH, Mayer-Rokitansky-Küster-Hauser, gynecology, vaginal aplasia, quality of life, MRKH syndrome
- Medical subject headings
- Mullerian aplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
questionnaires: WHOQOL-BREF (Quality of Life Study Questionnaire), FSFI (Female Sexual Function Index), FSDS-R (The Femala sexual distress scale-revised), Rosenberg scale (self-esteem assessment)
Semi-directed interviewOther
Semi-directed interview on the treatment pathway and the impact of utero-vaginal aplasia on intimate and personal life
| Study group | Role | What they receive |
|---|---|---|
| Patients with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome | Women patients with Mayer-Rokitansky-Küster-Hauser syndrome Receives: Other: Questionnaires; Other: Semi-directed interview | |
| Control group | patients followed in the gynecology department but not suffering from Mayer-Rokitansky-Küster-Hauser syndrome Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the overall quality of life of patients with Mayer-Rokitansky-Küster-Hauser syndrome.
Comparison of the score obtained on the WHOQOL BREF questionnaire between women with Mayer-Rokitansky-Küster-Hauser syndrome and the control population (score from 0 to 100, 0 corresponding to the worst quality of life and 100 to the best possible quality of life)
Measured: One hour after the inclusion
Secondary outcomes (6)
Evaluation of the quality of sexual life
FSFI questionnaire response score (Female sexual function Index). A total score of 26.55 has been proposed as a cut-off value for the diagnosis of sexual dysfunction, with the maximum score being 36
Measured: 1 hour after the inclusion
Assessment of distress regarding sexuality
Female Sexual Distress Scale-Revised (FSDS-R) questionnaire response score. A score > 15 indicates distress related to dysfunctional symptoms and therefore sexual dysfunction. The response to the first question is the best reflection of sexual distress.
Measured: 1 hour after the inclusion
Self-esteem assessment
Response score to the Rosenberg Self-Esteem Scale questionnaire. Score obtained between 10 and 40, a score <25 indicates very low self-esteem, and a score >39 corresponds to high self-esteem
Measured: 1 hour after the inclusion
Evaluation of gynecological monitoring of patients
existence or not of regular gynecological monitoring
Measured: 1 hour after the inclusion
Qualitative evaluation of the impact of utero-vaginal aplasia on intimate life
questions asked during the semi-directed interview in patients with Mayer-Rokitansky-Küster-Hauser syndrome
Measured: 1 hour after the inclusion
Evaluation of the functional impact of the treatment
The patient will be asked to participate in a semi-structured interview consisting of questions designed to analyze the impact of the condition and its treatment on the life experiences of women with Mayer-Rokitansky-Küster-Hauser syndrome.
Measured: 1 hour after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start4 Mar 2026
- Primary completion4 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mrkh SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prospective
- Enrolment
- 102 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186764
- Sponsor's protocol ID
- RC31/25/0251
- Other IDs
- ID-RCB
- Acronym
- MOQA
- Status last verified
- Mar 2026
- First submitted
- 3 Sep 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Overall Quality of Life and Gynecological Follow-up of Patients Treated for Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome at the Toulouse University Hospital
- ClinicalTrials.gov ID
- NCT07186764
- Acronym / sponsor ID
- MOQA / RC31/25/0251
- Conditions
- Mrkh Syndrome
- Keywords
- MRKH, Mayer-Rokitansky-Küster-Hauser, gynecology, vaginal aplasia, quality of life, MRKH syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 4 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Sep 2025 (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.
Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome affects 1 in 4,500 women and consists of utero-vaginal aplasia in 46 chromosom XX women, most often diagnosed in the presence of primary amenorrhea. This diagnosis, occurring in adolescence during the period of identity formation, can have significant psychological repercussions. This malformation can alter the body image and personal relationships of affected patients, beyond the impact on their sexual lives. Management around the disclosure is a crucial moment for these patients. Individual or group psychological support is systematically offered.
Several international studies show that these patients experience a decline in their quality of life, and they are more anxious and depressed. Participation in support groups improves this state.
The objective of this study is therefore to better understand Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome and the issues patients may face. For this reason, it seems essential to us to evaluate the overall quality of life, the quality of sexual life, the psychological state and the gynecological follow-up of women before or after treatment for vaginal aplasia.
Detailed description
Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome affects 1 in 4,500 women. In its classic form, it consists of uterovaginal aplasia in 46XX chromosom women, most often diagnosed in the presence of primary amenorrhea. This diagnosis, occurring in adolescence during the period of identity formation, can have significant psychological repercussions. Indeed, this uterovaginal aplasia is responsible for the inability to achieve vaginal penetration during sexual intercourse, the absence of menstruation, and the inability to conceive.
It is therefore easy to understand that this malformation can alter the body image and personal relationships of affected patients, beyond the impact on their sexual lives. Management around the time of disclosure is a crucial moment for these patients. Individual or group psychological support is systematically offered.
Before the 2010s, surgical techniques for vaginal creation were widely proposed, which was rejected in uterine transplant research protocols. Since 2014 (the first uterine transplant), expert physicians working with the Rare Gynecological Pathology Reference Centers have offered patients who wish to undergo vaginal self-dilation (the Frank technique). This neovagina allows for sexual intercourse with vaginal penetration. It is also an essential prerequisite in uterine transplant protocols, the criterion for which is a vaginal depth greater than 7 cm.
This condition requires a multidisciplinary approach. The discovery of this malformation raises many questions, due to the significant social, legal, and ethical implications: What do these patients think of their overall quality of life and their sexual quality? Do they have more psychological disorders than the general population? Are they well-monitored gynecologically? Does the treatment of utero-vaginal aplasia improve patients' quality of life? Several international studies show that these patients experience a decline in their quality of life; they are more anxious and more depressed. Participation in support groups improves this condition. These are older studies with cohorts of patients who most often benefited from surgical treatment, which is no longer the standard method today. These studies therefore do not allow an assessment of the current population.
The objective of this study is therefore to better understand Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome and the issues patients may face. To this end, we believe it is essential to assess the overall quality of life, sexual quality, psychological state, and gynecological follow-up of women before or after treatment for vaginal aplasia. Indeed, women must be able to fully experience their sexuality and achieve fulfillment through it. The impact of proposed medical treatments on sexuality must therefore be a concern for practitioners.
The evaluation of functional outcomes and the potential impact of our treatments must therefore be an integral part of follow-up.
Currently, there is little data regarding long-term outcomes after medical or surgical treatment.
The objective is to identify areas for improvement which could bring to the management and follow-up of this syndrome, in order to subsequently offer a personalized care pathway and better meet the needs of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome | – | Other: Questionnaires, Other: Semi-directed interviewWomen patients with Mayer-Rokitansky-Küster-Hauser syndrome |
| Control group | – | Other: Questionnairespatients followed in the gynecology department but not suffering from Mayer-Rokitansky-Küster-Hauser syndrome |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with Mayer-Rokitansky-Küster-Hauser syndrome and patients followed in gynecological consultation without the presence of this syndrome
Key inclusion criteria (11 listed)
- For Mayer-Rokitansky-Küster-Hauser patients:
- For the control population:
Key exclusion criteria (10 listed)
- For Mayer-Rokitansky-Küster-Hauser patients:
- For the control population:
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 |
|---|---|---|
| Questionnairesquestionnaires: WHOQOL-BREF (Quality of Life Study Questionnaire), FSFI (Female Sexual Function Index), FSDS-R (The Femala sexual distress scale-revised), Rosenberg scale (self-esteem assessment) | Other | Control group, Patients with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome |
| Semi-directed interviewSemi-directed interview on the treatment pathway and the impact of utero-vaginal aplasia on intimate and personal life | Other | Patients with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome |
Primary outcome
Evaluation of the overall quality of life of patients with Mayer-Rokitansky-Küster-Hauser syndrome.
Time frame: One hour after the inclusion
Comparison of the score obtained on the WHOQOL BREF questionnaire between women with Mayer-Rokitansky-Küster-Hauser syndrome and the control population (score from 0 to 100, 0 corresponding to the worst quality of life and 100 to the best possible quality of life)
6 secondary outcomes
Evaluation of the quality of sexual life
Time frame: 1 hour after the inclusion
Assessment of distress regarding sexuality
Time frame: 1 hour after the inclusion
Self-esteem assessment
Time frame: 1 hour after the inclusion
Evaluation of gynecological monitoring of patients
Time frame: 1 hour after the inclusion
Qualitative evaluation of the impact of utero-vaginal aplasia on intimate life
Time frame: 1 hour after the inclusion
Evaluation of the functional impact of the treatment
Time frame: 1 hour after the inclusion
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 2 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Mrkh Syndrome
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The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial
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Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility
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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?
An observational study of Mrkh Syndrome, run by University Hospital, Toulouse at 1 site in France.
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 10 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 2 Apr 2026. 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 France. 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 Audrey CARTAULT, MD (05 67 77 11 29 ext. +33, cartault.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the overall quality of life of patients with Mayer-Rokitansky-Küster-Hauser syndrome. (time frame: One hour after the inclusion). 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 2 Apr 2026.