Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
Recruiting
Phase 3
Interventional Study
Polycystic Ovary Syndrome
Reproductive Medicine
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 35
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 276 (estimated)
- Sponsor
- University Hospital, Lille · Other
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About This Trial
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 …
Trial Locations
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Eligibility 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 C…
Contacts