Clinical trial NCT05754593: Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group
Official title: Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control Group
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
ovarian reserve
fertility
auto-immunity
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 160
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: At baseline (day 0)
Secondary outcomes:
measure: 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.
timeFrame: At baseline (day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - service de neurologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Valérie BERNARD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Antoine BERNARD, MD
role: STUDY_CHAIR
References: