Evaluation of the Quality of Life and Gynecological Follow-up of Patients Treated for Mayer-Rokit… (NCT07186764) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Quality of Life and Gynecological Follow-up of Patients Treated for Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome
France102 participantsStarted 2026-03-04
Plain-language 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. 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the overall quality of life of patients with Mayer-Rokitansky-Küster-Hauser syndrome.