Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
- Conditions
- Polycystic Ovary SyndromeReproductive Medicine
- Interventions
- Dietary Supplement: Myo-Inositol + Levomefolic acidDietary Supplement: placebo
- Registration Number
- NCT03059173
- Lead Sponsor
- University Hospital, Lille
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 276
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Myo-Inositol + Levomefolic acid Myo-Inositol + Levomefolic acid The experimental group will receive the dietary supplement: 4 g of MYO + 0.736 mg of 5-MTHF, glucosamine salts per day per os (in 2 bags per day) in addition to the standard therapy (Clomiphene Citrate). Myo-Inositol + Levomefolic acid Clomiphene Citrate The experimental group will receive the dietary supplement: 4 g of MYO + 0.736 mg of 5-MTHF, glucosamine salts per day per os (in 2 bags per day) in addition to the standard therapy (Clomiphene Citrate). Placebo placebo The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts Placebo Clomiphene Citrate The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea) During one year Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC At each cycle during one year Rate of drop out at each cycle during one year Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study At each cycle during one year
Trial Locations
- Locations (1)
CHU de Lille hôpital Jeanne de Flandre
🇫🇷Lille, France