Myo-inositol supplementation for women with polycystic ovarian syndrome
Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate
This study is testing if taking Myo-inositol can help women with polycystic ovarian syndrome get pregnant more easily when combined with a fertility medication called Clomiphene Citrate.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Trial ID | NCT03059173 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women with PCOS who are seeking pregnancy and have not previously been treated with Clomiphene Citrate.
Not a fit: Patients with a BMI over 35 or those with other causes of infertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance ovulation induction success rates in women with PCOS, potentially leading to higher pregnancy rates.
How similar studies have performed: Previous studies have shown promising results with Myo-inositol supplementation in improving ovulation rates in women with PCOS, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.