Mrkh SyndromeMRKHPSYNCT05415540
Evolution of the Quality of Life and Experience of Young Women With Utero-vaginal Aplasia (MRKHPSY)
An observational study of Mrkh Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to evaluate the global evolution of the quality of life on patients diagnosed with MRKH syndrome (Mayer-Rokitansky-Kuster-Hauser), 8 to 10 years after the first research. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mrkh Syndrome
- What is being tested?
- Questionnaires
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 4 Oct 2022to 27 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient who participated in the initial T1 psychological component of the previous study (MRKH protocol)
Who may be able to join
- Patient aged of 18 years old or older
- Patient who participated in the initial T1 psychological component of the previous study (MRKH protocol)
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in the Quality of Life and Experience of Young Women With Utero-vaginal Aplasia (MRKHPSY)
This study aims to evaluate the global evolution of the quality of life on patients diagnosed with MRKH syndrome (Mayer-Rokitansky-Kuster-Hauser), 8 to 10 years after the first research.
Read the detailed description
Between 2012 and 2015, the French national reference center for rare gynecological pathologies (PGR) has conducted a study with 2 axis: a medical and a psychological section (clinical trial number NCT01911884).
The medical axis's aim was to compare the global and sexual quality of life of MRKH patients according to the mode of care (surgical or non-surgical) for vaginal aplasia. A total of 131 patients, with a mean age of 26.5 (±5.5) years old, were recruited for the study.
The quality of life was assessed considering 3 quality of life scales: global (WHOQOL-BREF) and sexual (FSFI and FSDS-R).
Quality of life scores and vaginal depth were compared and revealed that the surgery was not superior to self-dilation, whether in terms of quality of life or anatomical results. In addition, surgery was associated with complications in half of the cases. It should be mentioned that the overall quality of life of all 131 patients was similar to that of the general population, but significantly impaired in the psychosocial dimension in the younger patients. Notably, the quality of sexual life was not impaired with FSFI scores similar to those of the general population, but there was a profound sexual distress in nearly 71% of patients according to FSDS-R scores.
The psychological component of this initial research (called T1) focused specifically on the psychological, and more widely on the psychosocial, impact of the diagnosis of utero-vaginal aplasia in adolescent girls. 40 patients out of the 131 in the medical component participated (the first 40 contacted to participate in the medical component research). The results revealed a real experience of disability, and unexpectedly, addictive reactionary disorders (anorexia/bulimia or sport addiction), and an overrepresentation of heterosexual orientation compared to the general population. The absence of a uterus led to severe moral suffering regarding projections of access to biological motherhood.
This new research (called T2) involves the same population as T1 with the object of making each patient her own witness.
The purpose of the current study is to assess the evolution of this suffering, 8 to 10 years after the T1 study, using the same methodology as the previous study. The investigators hope to find an improvement in quality of life, a disappearance of addictive disorders and possibly a more vivid, but painful expression due to age, of the desire for motherhood, even if the uterus transplant is a source of hope.
Finding predictive factors of psychosocial difficulties would allow teh investigators to improve care practices, mainly psychological, which could also benefit other women with a rare disease affecting their sexuality and/or fertility.
- Conditions
- Mrkh Syndrome
- Being tested
- Questionnaires
- Keywords
- Mayer-Rokitansky-Kuster-Hauser Syndrome, Quality of life, Utero-vaginal aplasia
- 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
Subjects included in the study will answer questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of global quality of life
Evaluated by the World Health Organization Quality Of Life Brief Version (WHOQOL-BREF)
Measured: Day 0
Secondary outcomes (8)
Socio-professional integration
Socio-professional integration based on professional integration criteria. The potential consequences of this malformation on socio-professional integration are also diagnosed during the semi-directive clinical consultation and with the quality of life scale:
- Total score WHOQOL-BREF
Measured: Day 0
Socio-professional integration
Socio-professional integration based on professional integration criteria. The potential consequences of this malformation on socio-professional integration are also diagnosed during the semi-directive clinical consultation and with the quality of life scale:
- item 18 score (How satisfied are you with your capacity for work?)
Measured: Day 0
Socio-professional integration
Socio-professional integration based on professional integration criteria. The potential consequences of this malformation on socio-professional integration are also diagnosed during the semi-directive clinical consultation and with the quality of life scale:
-qualitative components mentioned during the clinical consultation regarding education and socio-professional integration
Measured: Day 0
Sexual quality of life
Sexual quality of life is assessed by two sex life self-questionnaires (Female Sexual Function Index FSFI and Female Sexual Dysfunction Scale-Revised FSFD).
Measured: Day 0
Addictive behavioural disorders
Description : Addictive behavioural disorders are diagnosed during the semi-directive clinical consultation. The semi-directive clinical consultation aims to promote the production of a speech by the patient on a given theme. This will be about the evolution of the personal history when the diagnosis was announced and the medical and/or surgical consequences that this diagnosis induced.
Measured: Day 0
Desire for motherhood
The desire for motherhood is identified during the semi-directive clinical consultation.
Measured: Day 0
The modalities to access to maternity
The modalities to access to maternity is identified during the semi-directive clinical consultation with three items: adoption, surrogacy, uterus transplantation;
Measured: Day 0
Modalities of their psychic functioning
by the semi-directive clinical interview and the Rorschach\&TAT with 13 variables:
- Adaptation to reality
- Type of anxiety:castration, loss of object, fragmentation, intrusion
- Body image and characteristics of human responses :whole, partial, blurred, attacked
- Self-representation:solid/fragile
- Capacity to deploy conflictual scenarios
- Female identification capability
- Access to ambivalence
- Modalities of thought investment: quality of laboration of the modes of apprehension: good/inadequate
- Quality of psychic functioning and defensive range: flexible and adapted/rigid and adapted/flexible and inadapted/rigid and inadapted
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start4 Oct 2022
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
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 Assistance Publique - Hôpitaux de ParisThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Rare Diseases, Necker Imagine Foundation, Laboratory of Clinical Psychology, Psychopathology and Psychoanalysis, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alaa CHEIKHELARD, Doctor, Principal investigatorKarinne Gueniche, MD, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415540
- Sponsor's protocol ID
- APHP211596
- Other IDs
- 2021-A02881-40
- Acronym
- MRKHPSY
- Status last verified
- Oct 2025
- First submitted
- 2 May 2022
- Last updated
- 20 Nov 2025
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Quality of Life and Experience of Young Women With Utero-vaginal Aplasia (MRKHPSY)
- ClinicalTrials.gov ID
- NCT05415540
- Acronym / sponsor ID
- MRKHPSY / APHP211596
- Conditions
- Mrkh Syndrome
- Keywords
- Mayer-Rokitansky-Kuster-Hauser Syndrome, Quality of life, Utero-vaginal aplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Foundation for Rare Diseases, Necker Imagine Foundation, Laboratory of Clinical Psychology, Psychopathology and Psychoanalysis, URC-CIC Paris Descartes Necker Cochin
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 13 Jun 2022 (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.
This study aims to evaluate the global evolution of the quality of life on patients diagnosed with MRKH syndrome (Mayer-Rokitansky-Kuster-Hauser), 8 to 10 years after the first research.
Detailed description
Between 2012 and 2015, the French national reference center for rare gynecological pathologies (PGR) has conducted a study with 2 axis: a medical and a psychological section (clinical trial number NCT01911884).
The medical axis's aim was to compare the global and sexual quality of life of MRKH patients according to the mode of care (surgical or non-surgical) for vaginal aplasia. A total of 131 patients, with a mean age of 26.5 (±5.5) years old, were recruited for the study.
The quality of life was assessed considering 3 quality of life scales: global (WHOQOL-BREF) and sexual (FSFI and FSDS-R).
Quality of life scores and vaginal depth were compared and revealed that the surgery was not superior to self-dilation, whether in terms of quality of life or anatomical results. In addition, surgery was associated with complications in half of the cases. It should be mentioned that the overall quality of life of all 131 patients was similar to that of the general population, but significantly impaired in the psychosocial dimension in the younger patients. Notably, the quality of sexual life was not impaired with FSFI scores similar to those of the general population, but there was a profound sexual distress in nearly 71% of patients according to FSDS-R scores.
The psychological component of this initial research (called T1) focused specifically on the psychological, and more widely on the psychosocial, impact of the diagnosis of utero-vaginal aplasia in adolescent girls. 40 patients out of the 131 in the medical component participated (the first 40 contacted to participate in the medical component research). The results revealed a real experience of disability, and unexpectedly, addictive reactionary disorders (anorexia/bulimia or sport addiction), and an overrepresentation of heterosexual orientation compared to the general population. The absence of a uterus led to severe moral suffering regarding projections of access to biological motherhood.
This new research (called T2) involves the same population as T1 with the object of making each patient her own witness.
The purpose of the current study is to assess the evolution of this suffering, 8 to 10 years after the T1 study, using the same methodology as the previous study. The investigators hope to find an improvement in quality of life, a disappearance of addictive disorders and possibly a more vivid, but painful expression due to age, of the desire for motherhood, even if the uterus transplant is a source of hope.
Finding predictive factors of psychosocial difficulties would allow teh investigators to improve care practices, mainly psychological, which could also benefit other women with a rare disease affecting their sexuality and/or fertility.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who participated in the initial T1 psychological component of the previous study (MRKH protocol)
Key inclusion criteria (2 listed)
- Patient aged of 18 years old or older
- Patient who participated in the initial T1 psychological component of the previous study (MRKH protocol)
Key exclusion criteria (1 listed)
- Refusal to participate in the study
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 |
|---|---|---|
| QuestionnairesSubjects included in the study will answer questionnaires | Other | – |
Primary outcome
Evaluation of global quality of life
Time frame: Day 0
Evaluated by the World Health Organization Quality Of Life Brief Version (WHOQOL-BREF)
8 secondary outcomes
Socio-professional integration
Time frame: Day 0
Socio-professional integration
Time frame: Day 0
Socio-professional integration
Time frame: Day 0
Sexual quality of life
Time frame: Day 0
Addictive behavioural disorders
Time frame: Day 0
Desire for motherhood
Time frame: Day 0
The modalities to access to maternity
Time frame: Day 0
Modalities of their psychic functioning
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Mrkh Syndrome
Not yet recruitingPhase 4
Vaginal Lactobacillus for Postoperative Microecology and Mucosal Repair in MRKH Syndrome
Mayer Rokitansky Kuster Hauser Syndrome
Active, not recruiting
The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial
Mayer Rokitansky Kuster Hauser Syndrome, Uterine Agenesis
Recruiting
Uterine Transplant for Women With Absolute Uterine Factor Infertility (AUFI)
Mayer Rokitansky Kuster Hauser Syndrome, Absence of Uterus
RecruitingObservational study
Evaluation of the Quality of Life and Gynecological Follow-up of Patients Treated for Mayer-Rokitansky-Küster-Hauser (MRKH) Syndrome
Mrkh Syndrome
Active, not recruiting
Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility
Absolute Uterine Infertility
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.
Alaa CHEIKHELARD, Doctor principal investigator
Karinne Gueniche, MD, PhD study director
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 Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 20 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of global quality of life (time frame: Day 0). 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 20 Nov 2025.