Multiple SclerosisFEMINISEPNCT05754593
Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group
A study testing Anti-Mullerian hormone (AMH) level, Antral follicle count (AFC) and Clinical assessment in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Anti-Mullerian hormone (AMH) level, Antral follicle count (AFC) and Clinical assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - service de neurologie
Bordeaux
Valérie BERNARD, MD, (0)5 56 79 56 79 ext. +33, valerie.bernard@chu-bordeaux.fr
Katy-Kim LATASTE, PhD, (0)5.57.82.25.10 ext. +33, katy-kim.lataste@chu-bordeaux.fr
About this study
Official title: Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control Group
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.
Read the 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 eighth 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Anti-Mullerian hormone (AMH) level, Antral follicle count (AFC), Clinical assessment
- Keywords
- multiple sclerosis, ovarian reserve, fertility, auto-immunity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Mullerian hormone (AMH) levelBiological
Measure of Anti-Mullerian hormone (AMH) level by blood sample
Antral follicle count (AFC)Other
Measure of Antral follicle count (AFC) by ultrasound imaging
Clinical assessmentOther
MS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded
| Study group | Role | What they receive |
|---|---|---|
| MS patients | Experimental | Diagnosis of multiple sclerosis based on McDonald Criteria 2017 Receives: Biological: Anti-Mullerian hormone (AMH) level; Other: Antral follicle count (AFC); Other: Clinical assessment |
| Controls | Active comparator | Healthy controls Receives: Biological: Anti-Mullerian hormone (AMH) level; Other: Antral follicle count (AFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start4 Dec 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie BERNARD, MD, Principal investigator, University Hospital, BordeauxAntoine BERNARD, MD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754593
- Sponsor's protocol ID
- CHUBX 2022/27
- Acronym
- FEMINISEP
- Status last verified
- Oct 2026
- First submitted
- 21 Feb 2023
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis, Compared to a Control Group
- ClinicalTrials.gov ID
- NCT05754593
- Acronym / sponsor ID
- FEMINISEP / CHUBX 2022/27
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, ovarian reserve, fertility, auto-immunity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 eighth 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS patients | Experimental | Biological: Anti-Mullerian hormone (AMH) level, Other: Antral follicle count (AFC), Other: Clinical assessmentDiagnosis of multiple sclerosis based on McDonald Criteria 2017 |
| Controls | Active comparator | Biological: Anti-Mullerian hormone (AMH) level, Other: Antral follicle count (AFC)Healthy controls |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Mullerian hormone (AMH) levelMeasure of Anti-Mullerian hormone (AMH) level by blood sample | Biological | Controls, MS patients |
| Antral follicle count (AFC)Measure of Antral follicle count (AFC) by ultrasound imaging | Other | Controls, MS patients |
| Clinical assessmentMS history and MS treatments and Expanded Disability Status Scale (EDSS) score will be recorded | Other | MS patients |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valérie BERNARD, MD principal investigator
University Hospital, Bordeaux
Antoine BERNARD, MD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Mullerian hormone (AMH) level, Antral follicle count (AFC) and Clinical assessment in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie BERNARD, MD ((0)5 56 79 56 79 ext. +33, valerie.bernard@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At baseline (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.