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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Biological: Anti-Mullerian hormone (AMH) level; Other: Antral follicle count (AFC); Other: Clinical assessment

• Registration Number: NCT05754593
• Lead Sponsor: University Hospital, Bordeaux

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.

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 fifth 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 Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-06
• Study Start: 2023-12-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MS patients	Anti-Mullerian hormone (AMH) level	Diagnosis of multiple sclerosis based on McDonald Criteria 2017
MS patients	Clinical assessment	Diagnosis of multiple sclerosis based on McDonald Criteria 2017
Controls	Anti-Mullerian hormone (AMH) level	Healthy controls
MS patients	Antral follicle count (AFC)	Diagnosis of multiple sclerosis based on McDonald Criteria 2017
Controls	Antral follicle count (AFC)	Healthy controls

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

CHU de Bordeaux - service de neurologie; 🇫🇷 Bordeaux, France