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

Launched by UNIVERSITY HOSPITAL, LILLE · Feb 15, 2017

Keywords

ClinConnect Summary

This clinical trial is studying whether a supplement called Myo-inositol can help women with Polycystic Ovary Syndrome (PCOS) who are trying to get pregnant. The goal is to see if taking Myo-inositol along with a common fertility medication called Clomiphene Citrate can improve the chances of ovulation and pregnancy. The study will involve two groups of women: one group will receive the Myo-inositol supplement along with another vitamin, while the other group will receive a placebo (a fake treatment) along with the same vitamin. The trial will last until either pregnancy occurs or the women have tried for six cycles without success.

To be eligible for this trial, participants must be women who wish to become pregnant and have been diagnosed with PCOS based on specific criteria, such as having a certain number of follicles in the ovaries or irregular menstrual cycles. They should not have been treated with Clomiphene Citrate in the past three months. Participants will need to provide informed consent and be covered by social security. It's important for potential participants to know that they will be part of a randomized study, meaning they may not know which treatment they are receiving, but everyone will receive care and support throughout the trial.

Gender

FEMALE

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 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.