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

Who is this study for? Patients with Polycystic Ovary Syndrome, Reproductive Medicine
What treatments are being studied? Clomiphene Citrate
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Lille hôpital Jeanne de Flandre
RECRUITING
Lille
Contact Information
Primary
Goeffrey ROBIN, MD
goeffrey.robin@chru-lille.fr
320446252
Time Frame
Start Date: 2023-09-12
Estimated Completion Date: 2027-12
Participants
Target number of participants: 276
Treatments
Experimental: Myo-Inositol + Levomefolic acid
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).
Placebo_comparator: Placebo
The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
Sponsors
Collaborators: Ministry of Health, France, Laboratoires Besins International
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov