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

Last updated: April 18, 2024
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting

Phase

3

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

placebo

Clomiphene Citrate

Myo-Inositol + Levomefolic acid

Clinical Study ID

NCT03059173
2015_68
2016-A01246-45
PHRC_N_15-0116
  • Ages 18-35
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Wishing pregnancy,
  • Having PCOS defined by the Rotterdam criteria: high antral follicle count (AFC) (> 19per ovary) and/or a disorder of the cycle and/or hyperandrogenism (at least two of thethree criteria),
  • Having never been treated with CC (or previous treatment with CC interrupted for > 3months).
  • Having received complete information and having signed consent.
  • Covered by social security

Exclusion

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.

Study Design

Total Participants: 276
Treatment Group(s): 3
Primary Treatment: placebo
Phase: 3
Study Start date:
September 12, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • CHU de Lille hôpital Jeanne de Flandre

    Lille,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.