NCT07027696

Brief Summary

This study looks at the sexual health of women who have experienced female genital mutilation (FGM) and who are receiving care at the Women's Center at Saint-Denis Hospital. It aims to better understand their sexual experiences, including the impact of past violence and trauma, and to explore how multidisciplinary care (such as psychological and sexological support) can help. The study also looks at what women expect from their care and how they feel about surgical or other types of support.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 11, 2025

Last Update Submit

June 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of the sexual function profile of women with female genital mutilation (FGM) during consensual sexual activity, using a structured clinical sexological evaluation that accounts for histories of violence.

    6 months

Eligibility Criteria

Age15 Years+
Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult women who have experienced female genital mutilation (FGM) or are considered to be excised, and who are consulting at the Maison des Femmes (Women's House) of the Saint-Denis Hospital in France. These women are engaged in a multidisciplinary care pathway addressing the consequences of FGM. Most are migrants who have faced various forms of violence, either in their country of origin or during their migration journey.

You may qualify if:

  • Women with female genital mutilation (FGM), or considered to be excised, consulting at the Maison des Femmes (Women's House) at Saint-Denis Hospital.
  • Women enrolled in the multidisciplinary care pathway for FGM.

You may not qualify if:

  • \- Women under the age of 15.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Saint-Denis, France, France

Location

MeSH Terms

Conditions

Sexual Dysfunctions, PsychologicalStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Mental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 18, 2025

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

June 18, 2025

Record last verified: 2025-06

Locations