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

Phase 3RecruitingNCT03059173

University Hospital, Lille276 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

276

Conditions

Polycystic Ovary Syndrome Reproductive Medicine

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Total resistance rate under CC for ovulation induction in patients with PCOS.

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.

Time frame: At each cycle during 4 months

Secondary Outcomes

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