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

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anti-Mullerian hormone (AMH) level
Antral follicle count (AFC)
Clinical assessment
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring multiple sclerosis, ovarian reserve, fertility, auto-immunity

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • CHU de Bordeaux - service de neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MS patients

Controls

Arm Description

Diagnosis of multiple sclerosis based on McDonald Criteria 2017

Healthy controls

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 21, 2023
Last Updated
March 6, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05754593
Brief Title
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group
Acronym
FEMINISEP
Official Title
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control Group
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, ovarian reserve, fertility, auto-immunity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie BERNARD, MD
Phone
(0)5 56 79 56 79
Ext
+33
Email
valerie.bernard@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde DELOIRE, PhD
Phone
(0)5.57.82.12.75
Ext
+33
Email
mathilde.deloire@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie BERNARD, MD
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BERNARD, MD
Organizational Affiliation
CHU Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Bordeaux - service de neurologie
City
Bordeaux
Country
France

12. IPD Sharing Statement

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

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