Myo-inositol supplementation for women with polycystic ovarian syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of Myo-inositol supplementation in reducing resistance to Clomiphene Citrate in women diagnosed with polycystic ovarian syndrome (PCOS) who wish to conceive. The study is designed as a controlled, randomized, and double-blinded trial, where participants will be divided into two groups: one receiving Myo-inositol and levomefolic acid alongside Clomiphene Citrate, and the other receiving a placebo with levomefolic acid. The supplementation will begin at least one month prior to Clomiphene treatment and will continue until pregnancy is achieved or after six ovulatory cycles without success.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU de Lille hôpital Jeanne de Flandre
  Lille, France Recruiting

Study contacts

• Principal investigator: Goeffrey Robin, MD — University Hospital, Lille
• Study coordinator: Goeffrey ROBIN, MD
• Email: goeffrey.robin@chru-lille.fr
• Phone: 320446252

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.