NCT05754593

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
6mo left

Started Dec 2023

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

First Submitted

Initial submission to the registry

February 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

December 4, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

February 21, 2023

Last Update Submit

November 19, 2025

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisovarian reservefertilityauto-immunity

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline (day 0)

Secondary Outcomes (1)

  • 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.

    At baseline (day 0)

Study Arms (2)

MS patients

EXPERIMENTAL

Diagnosis of multiple sclerosis based on McDonald Criteria 2017

Biological: Anti-Mullerian hormone (AMH) levelOther: Antral follicle count (AFC)Other: Clinical assessment

Controls

ACTIVE COMPARATOR

Healthy controls

Biological: Anti-Mullerian hormone (AMH) levelOther: Antral follicle count (AFC)

Interventions

Anti-Mullerian hormone (AMH) levelBIOLOGICAL

Measure of Anti-Mullerian hormone (AMH) level by blood sample

ControlsMS patients
Antral follicle count (AFC)OTHER

Measure of Antral follicle count (AFC) by ultrasound imaging

ControlsMS patients
Clinical assessmentOTHER

MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded

MS patients

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de neurologie

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Anti-Mullerian HormoneFloors and Floorcoverings

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Testicular HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsFacility Design and ConstructionArchitectureTechnology, Industry, and Agriculture

Study Officials

  • Valérie BERNARD, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Antoine BERNARD, MD

    University Hospital, Bordeaux

    STUDY CHAIR

Central Study Contacts

Valérie BERNARD, MD

CONTACT

(0)5 56 79 56 79valerie.bernard@chu-bordeaux.fr

Mathilde DELOIRE, PhD

CONTACT

(0)5.57.82.12.75mathilde.deloire@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 6, 2023

Study Start

December 4, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 25, 2025

Record last verified: 2025-11

Locations

FR(1)