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

About this trial

Last updated a month ago

Study ID

2015_68

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18 to 35 Years

Female

Trial Timing

Started 3 years ago

What is this trial about?

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.

What are the participation requirements?

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.