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RecruitingNAINTERVENTIONAL

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

This study aims to understand if multiple sclerosis (MS) affects a woman's egg reserve, which is a key part of her fertility. They will compare women with MS, aged 25 to 35, to healthy women of the same age. Researchers want to see if MS might make it harder for women to have children by looking at two specific fertility markers: a hormone level in the blood (AMH) and counting small follicles (eggs) in the ovaries using an ultrasound scan. The goal is to see if MS might lead to an earlier reduction in egg reserve compared to women without MS. This information could help guide discussions about family planning for women with MS.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Bordeaux
Enrolment target
160
Start
04 Dec 2023
Estimated completion
01 Dec 2026

What is this study about?

You might be wondering if living with multiple sclerosis (MS) could affect your ability to have children. This study is being done to explore that very question. Researchers are specifically looking at something called 'ovarian reserve', which is a way of measuring a woman's potential to have eggs, and therefore, her fertility. They want to compare the ovarian reserve of women with MS to that of healthy women.

MS is a condition that affects the brain and spinal cord, and it often affects women of childbearing age – around 30 years old, for example. Because of this, it's really important to understand if MS or its treatments might influence a woman's fertility potential. While a few smaller studies have looked into this before, their results haven't always agreed, and there haven't been many participants. This new research aims to provide clearer answers.

Understanding if MS can affect ovarian reserve is important. If it does, it could help doctors and women with MS have earlier conversations about family planning and support options, such as fertility preservation, if needed. This study is being carried out in a hospital in Bordeaux, France, by a team of doctors and specialists.

Key takeaways

  • The study investigates if MS affects a woman's egg reserve and fertility.
  • It compares women with MS to healthy women aged 25-35.
  • Tests involve a blood sample for a hormone (AMH) and an ultrasound scan of the ovaries (AFC).
  • Results will be shared, and follow-up gynaecology appointments are arranged for abnormal findings.
  • The study aims to provide more clarity on MS and fertility for family planning discussions.

Who may be eligible?

To join this study, you need to be a woman between 25 and 35 years old. You must have a diagnosis of multiple sclerosis, confirmed by specific medical guidelines (called McDonald Criteria 2017). You also need to speak French fluently and not have any difficulties understanding information. Finally, you should be covered by health insurance and be willing to take part and sign a consent form.

There are certain reasons why you wouldn't be able to join. These include if you've had surgery on your ovaries, have specific genetic conditions like Turner Syndrome or a particular change in the FMR1 gene, or if you have endometriosis that might affect your ovaries. If you've had chemotherapy or radiotherapy targeting your pelvis, you also wouldn't be able to participate. Pregnant or breastfeeding women cannot join, nor can individuals who are legally unable to give their consent, such as those in prison or minors.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a woman between 25 and 35 years old?
  2. Have you been diagnosed with multiple sclerosis?
  3. Do you speak and understand French well?
  4. Are you covered by health insurance?
  5. Have you had any ovarian surgery (e.g., for cysts)?
  6. Are you currently pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what you can expect. You'll be asked to provide some information about yourself through a short questionnaire. You will have a blood test to measure your Anti-Mullerian Hormone (AMH) level, which can be done at any point in your menstrual cycle. You'll also have an ultrasound scan to count your 'antral follicles' (small sacs in your ovaries containing eggs). This scan is ideally done between day 2 and day 8 of your period. Both tests will be done at the Pellegrin Hospital in Bordeaux.

About two months after your tests, you will receive your results during a phone or video consultation. If any of your results are unusual, a specific appointment will be arranged for you to see a gynaecologist for further discussion and advice. The study lasts for the time it takes to complete these tests and receive your results.

Potential risks and benefits

Participating in this study might offer you the benefit of gaining a better understanding of your own ovarian reserve, which is a part of your fertility potential. This information could be useful for your family planning discussions. As for risks, the blood test carries a very small risk of bruising or discomfort, and the ultrasound scan is generally very safe with no known risks. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • CHU de Bordeaux - service de neurologie
    Verified postcode
    Bordeaux, France· Recruiting

Common questions

What is 'ovarian reserve'?

Ovarian reserve refers to the number and quality of eggs a woman has left in her ovaries, which indicates her fertility potential.

What are AMH and AFC?

AMH is a hormone measured in a blood test, and AFC is the Antral Follicle Count, which is determined by an ultrasound scan. Both are used to estimate ovarian reserve.

Do I need to be having my period for the tests?

The AMH blood test can be done at any time. The ultrasound (AFC) is ideally done between day 2 and day 8 of your menstrual cycle.

Will I get my test results?

Yes, you will receive your results during a phone or video consultation about two months after your tests. If anything is unusual, you'll have an appointment with a gynaecologist.

Where is this study taking place?

This study is being conducted at Pellegrin Hospital in Bordeaux, France.

How to find out more

Valérie BERNARD, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Ovarian Reserve Concerning Patients With Multiple S…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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