RecruitingPhase 3NCT03059173

Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome

Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate

Sponsor

University Hospital, Lille

Enrollment

276 participants

Start Date

Sep 12, 2023

Study Type

INTERVENTIONAL

Conditions

Polycystic Ovary Syndrome Reproductive Medicine

Summary

The main objective will be to check if MyoInositol (MYO) reduces the total resistance rate to Clomiphene Citrate (CC). For this, our study will be controlled, randomized and double blinded. It will include patients with PCOS (polycystic ovary syndrome, defined by the Rotterdam criteria) who wish to become pregnant and are eligible to simple ovulation induction by CC. Half of them will receive MYO + levomefolic acid (5-MTHF) in addition to the CC, while the other half will receive a placebo containing only 5-MTHF in addition to the CC. The MYO supplementation will be initiated at least one month before taking CC and will be continued throughout this treatment until pregnancy or before switching to another type of treatment for ovulation induction if no pregnancy is obtained after 6 ovulatory cycles.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether taking myo-inositol (a natural supplement) alongside a common fertility drug (clomiphene citrate) improves ovulation and pregnancy rates in women with Polycystic Ovary Syndrome (PCOS) who are trying to conceive. **You may be eligible if...** - You have PCOS diagnosed by standard criteria (irregular cycles, high male hormone levels, or a high count of follicles in the ovaries) - You are trying to become pregnant - You have never been treated with clomiphene citrate (a fertility drug), or your last treatment was more than 3 months ago - You are enrolled in or covered by a social security/health insurance system **You may NOT be eligible if...** - You had a bad reaction to clomiphene citrate in a previous treatment - Your BMI is above 35 - You have another hormonal condition causing irregular ovulation (such as high prolactin levels or hypothalamic problems) - You are currently pregnant - There are other male or female fertility problems that need specific treatment - You have had an ovarian drilling procedure in the past - You lack immunity to rubella (German measles) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTMyo-Inositol + Levomefolic acid

Dietary supplement Gynositol® MTHF containing myo-inositol (4 g) and Levomefolic acid on glucosamine salts(0.736 mg) in a same bags Supplementation started on average one month before treatment with Clomiphene citrate and continued throughout cycles of Clomiphene citrate (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle.

DRUGClomiphene Citrate

Clomiphene citrate 50 mg. taking D2 to D6 of each cycle (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle and the dose will be increased if necessary.

DIETARY_SUPPLEMENTplacebo

a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts