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Recruiting Phase 3 NCT03059173

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

Phase 3 – large-scale trial before approval
Conditions: Polycystic Ovary Syndrome Reproductive Medicine

Sponsor: University Hospital, Lille

trial.available_in: БГ
Overview
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.
Who can participate
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.
Interventions
Myo-Inositol + Levomefolic acid
DIETARY_SUPPLEMENT
Clomiphene Citrate
DRUG
placebo
DIETARY_SUPPLEMENT
Locations 1
France (1)
CHU de Lille hôpital Jeanne de Flandre
Lille
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
35 Years
Healthy volunteers
No
Start date
12.09.2023
Completion date
01.12.2027
Registry ID
NCT03059173
Source
clinicaltrials.gov
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