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

University Hospital, Lille

Status and phase: Enrolling; Phase 3

Conditions: Reproductive Medicine; Polycystic Ovary Syndrome

Treatments: Dietary Supplement: placebo; Dietary Supplement: Myo-Inositol + Levomefolic acid; Drug: Clomiphene Citrate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03059173

2015_68

2016-A01246-45 (Other Identifier)

PHRC_N_15-0116 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

276 participants in 2 patient groups, including a placebo group

Myo-Inositol + Levomefolic acid

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Myo-Inositol + Levomefolic acid

Drug: Clomiphene Citrate

Placebo

Placebo Comparator group

Description:

The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts

Treatment:

Dietary Supplement: placebo

Drug: Clomiphene Citrate