Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03059173

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Reproductive Medicine Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Lille hôpital Jeanne de Flandre

Lille, France

Location status: Recruiting

Location contact

Geoffroy Robin, MD, PhD

CONTACT

Geoffroy Robin, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Myo-Inositol + Levomefolic acid

Dietary Supplement

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.

Other names: Myo + [6S]-5-MethylTetrahydrofolate(5-MTHF) ou Gynositol (R)

Clomiphene Citrate

Drug

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.

Placebo

Dietary Supplement

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

Primary outcomes

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

    Time frame: At each cycle during 4 months

    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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Goeffrey ROBIN, MD

CONTACT

[email protected]

320446252 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Laboratoires Besins International
  • Ministry of Health, France

Registry information

Official study title

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

Acronym: MYOPK

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2017
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.