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Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
Sponsor: University Hospital, Lille
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.
Official title: Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate
Key Details
Gender
FEMALE
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
276
Start Date
2023-09-12
Completion Date
2027-12
Last Updated
2024-04-19
Healthy Volunteers
No
Interventions
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
Locations (1)
CHU de Lille hôpital Jeanne de Flandre
Lille, France