Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group (FEMINISEP)

November 19, 2025 updated by: University Hospital, Bordeaux

Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control Group

The investigators want to evaluate ovarian reserve concerning patients with multiple sclerosis, compared to a control group of healthy women. This study will include women from 25 to 35 years old.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple sclerosis is an inflammatory disease of central nervous system, with a prevalence rate in France of 1 case/1000 subjects. The average age at diagnosis is 30 years old and it affects especially women, with a sex ratio of 3 women for 1 men. Multiples sclerosis concerns women at a moment when fertility is a main issue.

Few studies suggest that there is an negative impact of multiple sclerosis on ovarian reserve, with a combined mechanism ( inflammatory and autoimmune mechanism). The investigators can hypothesize that patients with multiple sclerosis are more predisposed to have primary ovarian insufficiency.

Ovarian reserve is evaluated by Anti-Mullerian Hormone (AMH) dosage and antral follicle count (AFC) by ultrasound imaging.AMH levels can be measured at every moment of the menstrual cycle whereas AFC is preferentially performed between the second and the eighth day of the menstrual cycle. The combined use of this two markers is well known to be correlated with ovarian reserve. Only a few studies have evaluated ovarian reserve in patients with multiple sclerosis. Besides, there is only a few number of participants and results are contradictory. A decrease of ovarian reserve identified among patients with multiple sclerosis could lead to an orientation in a fertility preservation center.

This project is a monocentric study realized at Pellegrin Hospital - Bordeaux. Patients with multiple sclerosis belong to a cohort of the neurology center. Healthy women come from a volunteer base contacted by email.The two groups are matched thanks to answers of a short questionnaire.Measure of AMH level is performed at pellegrin Hospital at the medical laboratory. Ultrasound imaging is performed by the center of women imagery at Pellegrin Hospital. Results are communicated by teleconsultation two months later. If there is an anormal result, a specific appointment will be organized with a gynecologist.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux - Service de neurologie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valérie BERNARD, MD
        • Sub-Investigator:
          • Alexis MONTCUQUET, MD
        • Sub-Investigator:
          • Jean-Christophe OUALLET, MD
        • Sub-Investigator:
          • Pauline BOISSONNIERE, MD
        • Sub-Investigator:
          • Pauline BOUCHARD, MD
        • Sub-Investigator:
          • Aurélie RUET, Prof
        • Sub-Investigator:
          • Arnaud GAGNOL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Reproductive women between 25 and 35 years old ;
  • MS Patient : Diagnosis of multiple sclerosis based on McDonald Criteria 2017;
  • French-speaking, without comprehension disorders ;
  • being affiliated to health insurance ;
  • Willing to participate and to sign informed consent.

Exclusion Criteria:

  • History of ovarian surgery (cystectomy, annexectomy) ;
  • Turner Syndrome ;
  • fragile X messenger ribonucleoprotein 1 (FMR1) premutation ;
  • Endometriosis with a risk of ovarian reserve alteration ;
  • History of chemotherapy or pelvic radiotherapy ;
  • Pregnant or breastfeeding women ;
  • patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MS patients
Diagnosis of multiple sclerosis based on McDonald Criteria 2017
Other: Clinical assessment
MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded
Biological: Anti-Mullerian hormone (AMH) level
Measure of Anti-Mullerian hormone (AMH) level by blood sample
Other: Antral follicle count (AFC)
Measure of Antral follicle count (AFC) by ultrasound imaging
Active Comparator: Controls
Healthy controls
Biological: Anti-Mullerian hormone (AMH) level
Measure of Anti-Mullerian hormone (AMH) level by blood sample
Other: Antral follicle count (AFC)
Measure of Antral follicle count (AFC) by ultrasound imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of Anti-Mullerian hormone (AMH) level by blood sample to compare ovarian reserve between patients with multiple sclerosis versus healthy controls from 25 to 35 years old.
Time Frame: At baseline (day 0)
At baseline (day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure of Antral follicle count (AFC) by ultrasound imaging to compare ovarian reserve between patients with multiple sclerosis versus healthy controls from 25 to 35 years old.
Time Frame: At baseline (day 0)
At baseline (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Valérie BERNARD, MD, University Hospital, Bordeaux
  • Study Chair: Antoine BERNARD, MD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Estimated)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2022/27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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