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Clinical Trials in France / NCT03059173
Recruiting Phase 3

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

NCT03059173 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Lille
Phase
Phase 3
Started
2023-09-12
Last updated
2026-04-22

Condition(s) studied

Polycystic Ovary SyndromeReproductive Medicine

Investigational drug(s) / intervention(s)

Myo-Inositol + Levomefolic acidClomiphene Citrateplacebo

Myo-Inositol + Levomefolic acid: Dietary supplement Gynositol® MTHF containing myo-inositol (4 g) and Levomefolic acid on glucosamine salts(0.736 mg) in a same bags Supplementation started on average one month before treatment with Clomiphene citrate and continued throughout cycles of Clomiphene citrate (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle.

Clomiphene Citrate: Clomiphene citrate 50 mg. taking D2 to D6 of each cycle (maximum 9 cycles). Treatment will be delivered during ultrasound visit at D12 of each cycle and the dose will be increased if necessary.

placebo: a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Total resistance rate under CC for ovulation induction in patients with PCOS. — At each cycle during 4 months
    The total resistance to CC is defined by failure to ovulate at least one time during 4 subsequent cycles in women requiring 150 mg/day from D2 to D6.

Trial sites (1)

FacilityCityRegionStatus
CHU de Lille hôpital Jeanne de Flandre Lille France Recruiting

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Other trials for the same condition

Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With "Classic" Polycystic Ovary Syndrome (PCOS) Recruiting
Evaluation of the Venous Thrombotic Biological Profile of Different PCOS Phenotypes: French Cross-sectional Study Active, not recruiting
Glucose Profiles in Women With Polycystic Ovary Syndrome Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03059173 on ClinicalTrials.gov ↗ ← All trials in France