NCT03059173

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

Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome
• Reproductive Medicine

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-12
• Primary completion: 2027-09-12
• Completion: 2027-12-01
• First posted: 2017-02-23
• Last updated: 2024-04-19

Locations

1 site across 1 country: France