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

NCT03059173 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2026-04-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Laboratoires Besins International

    collaborator INDUSTRY

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Goeffrey Robin, MD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2027-09-12
Completion
2027-12-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03059173 on ClinicalTrials.gov