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Brief Summary

CONTEXT A desire for pregnancy is common in young patients with multiple sclerosis (MS). The impact of MS on women fertility is debated, and the impact of disease-modifying therapies (DMTs) on fertility is not well known. Antimüllerian hormone (AMH) is a representative biomarker of ovarian reserve that can be used to explore this issue. OBJECTIVES To examine the impact of MS activity and related DMTs on ovarian reserve measured by serum AMH level. METHODOLOGY Retrospective multicentre study based on clinical and blood samples from patients included in the OFSEP cohort. A serum sample from more than 800 MS and 96 NMOSD women aged 18-35 will be available for AMH dosing. The results obtained will be interpreted taking into account the age, the inflammatory activity of the disease, the disability (EDSS) and the previous and current DMTs used. STATISTICAL ANALYSIS Spearman correlation coefficient will be calculated in univariate analysis between serum AMH level and number of relapses that occurred during the 2 years before blood sample collection. For multivariable analysis, multiple mixed linear regression will be performed with AMH level as dependant outcome and number of relapses, age, DMTs (highly active, moderately active or no treatment), disease duration and disability (measured using EDSS) as independent variables. The center will be considered as random-effect. For AMH level categorized as normal or not, mixed logistic regression will be performed with aforementioned covariates. These analyses will be completed by a mediation analysis between AMH level, number of relapses and DMTs with age, EDSS and disease duration as adjustments covariates. EXPECTED RESULTS : Evaluation of the potential relationship between AMH levels and MS or NMOSD activity at the first years of the illness. Evaluation of the potential impact of MS and NMOSD treatments on ovarian reserve. Optimization of the indications of fertility preservation for MS and NMOSD female patients.

Conditions

Fertility Multiple Sclerosis Neuromyelitis Optica Spectrum Disorders

Keywords

FertilityAnti-Mullerian Hormone (AMH)Multiple sclerosis (MS)FemaleDisease activity

Outcome Measures

Primary Outcomes (1)

the evaluation of MS/NMOSD inflammatory activity on the serum AMH level (ng/ml)
Disease activity will be evaluated on the number of relapses that occurred during the 2 years before blood sample collection and total number of relapses, taking disease duration into account. The measurement of AMH level will be performed using the electrochemiluminescence method with a Cobas® e411 analyzer (Roche Diagnostics, Meylan, France). This immunoassay is based on a sandwich format between the analyte and the two antibodies: a biotinylated AMH-specific mouse monoclonal capture antibody and a second ruthenium-labeled AMH mouse monoclonal antibody. This assay is a fully automated, robust and precise method. Repeatability and intermediate precision calculated on serum samples range from 1.1% to 1.8% and 3.3% to 4.4%, respectively. The assay time is 18 minutes and the measuring range is from 0.01 to 23 ng/ml. The threshold of inf at1 ng/ml will be considered to be a proof of severe decrease in ovarian reserve
period of 2 years before blood samples

Secondary Outcomes (1)

Evaluation of the potential impact of previous treatments used on AMH level

Study Arms (1)

MS / NMOSD female patients

MS / NMOSD female patients , aged between 18 and 35, with or without MS treatment

Biological: blood sample to analyse AMH level on the serum

Interventions

blood sample to analyse AMH level on the serumBiological

Evaluation of MS/NMOSD inflammatory activity on the serum AMH level (ng/ml)

MS / NMOSD female patients

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 35 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Women, with age between 18 at 35, with a diagnosis of MS or NMOSD , present in EDMUS database, which has a blood sample in the OFSEP cohort

You may qualify if:

Female

Sponsors & Collaborators

ARSEP foundation
Type not reportedcollaborator
Observatoire Français de la sclérose en plaques (OFSEP)
Type not reportedcollaborator

Study Sites (27)

CHU Amiens

Amiens, France

CHU Besancon

Besançon, France

CHU Bordeaux

Bordeaux, France

CHU Caen

Caen, France

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

AP-HP - Créteil

Créteil, France

CHU Dijon

Dijon, France

CHU Grenoble

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum for antimüllerian l(AMH) level

MeSH Terms

Conditions

Multiple SclerosisNeuromyelitis Optica

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMyelitis, TransverseOptic NeuritisOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

Pierre Clavelou
University Hospital, Clermont-Ferrand
PRINCIPAL INVESTIGATOR

Enrollment

800 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Target Duration: 2 Years
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 6, 2025

First Posted

September 10, 2025

Study Start

January 1, 2018

Actual (reported)

Evaluation of the Impact of Multiple Sclerosis and Its Treatments on Women Fertility

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

MS / NMOSD female patients

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Evaluation of the Impact of Multiple Sclerosis and Its Treatments on Women Fertility

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

MS / NMOSD female patients

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations