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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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 + folic acid (FA) in addition to the CC, while the other half will receive a placebo containing only FA 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Collaborators: Laboratoires Besins International; Ministry of Health, France
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Folic Acid; Inositol; Vitamin B Complex; Zuclomiphene

Criteria

Inclusion Criteria:

• Wishing pregnancy,

• Having PCOS defined by the Rotterdam criteria: high antral follicle count (AFC) (> 19 per ovary) and/or a disorder of the cycle and/or hyperandrogenism (at least two of the three criteria),

• Having never been treated with CC (or previous treatment with CC interrupted for > 3 months).

• Having received complete information and having signed consent.

• Covered by social security

Exclusion Criteria:

• Intolerance to CC in previous treatment,

• BMI > 35,

• Other associated cause of oligoanovulation requiring specific treatment (eg., Hyperprolactinemia or functional hypothalamic anovulation),

• Ongoing pregnancy at the time of CC initiation,

• Other male or female cause of hypo-fertility,

• History of ovarian drilling,

• Negative rubella serology.