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RecruitingNCT03059173MYOPKUpdated Apr 22, 2026

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

A Phase 3 interventional study of Myo-Inositol + Levomefolic acid and Clomiphene Citrate in Polycystic Ovary Syndrome and Reproductive Medicine, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by University Hospital, Lille · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years later.
Phase
Phase 3
Study type
Interventional
Enrollment
276
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

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.

02

Conditions studied

  • Polycystic Ovary Syndrome
  • Reproductive Medicine

Keywords

  • Polycystic ovary syndrome
  • Reproductive medicine
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.

This study's planned enrollment of 276 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Intolerance to CC in previous treatment,
  • BMI > 35,
  • Other associated cause of oligoanovulation requiring specific treatment (eg., Hyperprolactinemia or functional hypothalamic anovulation),
  • Ongoing pregnancy at the time of CC initiation,
  • Other male or female cause of hypo-fertility,
  • History of ovarian drilling,
  • Negative rubella serology.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
276 participants (estimated)

Study arms

  • 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).

    Dietary Supplement: Myo-Inositol + Levomefolic acid · Drug: 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

    Drug: Clomiphene Citrate · Dietary Supplement: placebo

Interventions

  • Dietary supplementMyo-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.

    Also known as: Myo + [6S]-5-MethylTetrahydrofolate(5-MTHF) ou Gynositol (R)

  • DrugClomiphene 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 supplementplacebo

    a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts

06

What researchers measure

Primary outcomes

  1. Total resistance rate under CC for ovulation induction in patients with PCOS.

    The total resistance to CC is defined by failure to ovulate at least one time during 4 subsequent cycles in women requiring 150 mg/day from D2 to D6.

    Time frame: At each cycle during 4 months

Secondary outcomes

  1. Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC

    Time frame: At each cycle during one year

  2. Rate of drop out

    Time frame: at each cycle during one year

  3. Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)

    Time frame: During one year

  4. Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study

    Time frame: At each cycle during one year

07

Study locations

1 of 1 sites recruiting
  • CHU de Lille hôpital Jeanne de Flandre
    Lille, France
    • Geoffroy Robin, MD, PhD · Contact
    • Geoffroy Robin, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • Rolland AL, Peigne M, Plouvier P, Dumont A, Catteau-Jonard S, Dewailly D. Could myo-inositol soft gel capsules outperform clomiphene in inducing ovulation? Results of a pilot study. Eur Rev Med Pharmacol Sci. 2017 Jun;21(2 Suppl):10-14. PubMed 28724178 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03059173
Lead sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France, Laboratoires Besins International
Responsible party
Sponsor
First posted
Feb 23, 2017
Start date
Sep 12, 2023
Primary completion
Sep 12, 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 22, 2026

Study contacts

Goeffrey ROBIN, MD
Contact
goeffrey.robin@chru-lille.fr
320446252 ext. +33
Goeffrey Robin, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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