Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Myo-Inositol + Levomefolic acid, Clomiphene Citrate, placebo.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome, Reproductive Medicine. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate
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.
Interventions
- Dietary supplement 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. - Drug 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. - Dietary supplement placebo
a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
Primary outcome measures
- Total resistance rate under CC for ovulation induction in patients with PCOS. [Time frame: At each cycle during 4 months]
Secondary outcome measures (4)
- Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC [Time frame: At each cycle during one year]
- Rate of drop out [Time frame: at each cycle during one year]
- Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea) [Time frame: During one year]
- Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study [Time frame: At each cycle during one year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Lille hôpital Jeanne de Flandre — Lille
Publications
- Rolland AL, Peigne M, Plouvier P, Dumont A, Catteau-Jonard S, Dewailly D. Could myo-inositol soft gel capsules outperform clomiphene in inducing ovulation? Results of a pilot study. Eur Rev Med Pharmacol Sci. 2017 Jun;21(2 Suppl):10-14. PMID 28724178
Identifiers
NCT: NCT03059173 · 2015_68 · 2016-A01246-45 · PHRC_N_15-0116