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

PHASE3RecruitingINTERVENTIONAL
Enrollment

276

Participants

Timeline

Start Date

September 12, 2023

Primary Completion Date

September 12, 2027

Study Completion Date

December 31, 2027

Conditions
Polycystic Ovary SyndromeReproductive Medicine
Interventions
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

Trial Locations (1)

Unknown

RECRUITING

CHU de Lille hôpital Jeanne de Flandre, Lille

Sponsors
All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

collaborator

Laboratoires Besins International

INDUSTRY

lead

University Hospital, Lille

OTHER