ClinicalTrials.Veeva

Menu

Evaluation of the Quality of Life and Gynecological Follow-up of Patients Treated for Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome (MOQA)

T

Toulouse University Hospital

Status

Not yet enrolling

Conditions

Mrkh Syndrome

Treatments

Other: Semi-directed interview
Other: Questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT07186764
RC31/25/0251
ID-RCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

102 participants in 2 patient groups

Patients with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome
Description:
Women patients with Mayer-Rokitansky-Küster-Hauser syndrome
Treatment:
Other: Questionnaires
Other: Semi-directed interview
Control group
Description:
patients followed in the gynecology department but not suffering from Mayer-Rokitansky-Küster-Hauser syndrome
Treatment:
Other: Questionnaires

Trial contacts and locations

1

Loading...

Central trial contact

Audrey CARTAULT, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems