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

Study acronym: MYOPK
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study Status, Referencesv13
  2. Trial status: Not Yet Recruiting to Recruitingv12 Show 4 more changesShow less
    • Primary completion date: Mar 2024 to Sep 12, 2027
    • Start date changed from estimate of Mar 2022 to Sep 12, 2023
    • Study sites: 0 to 1
    • Study completion date: Mar 2024 to Dec 2027
  3. Start date: Dec 2021 to Mar 2022
    • Primary and study completion dates: Dec 2023 to Mar 2024
    v11
  4. Start date: Sep 2021 to Dec 2021
    • Primary and study completion dates: Sep 2023 to Dec 2023
    • Interventions: Clomiphene Citrate (Drug), Inofolic (r) (Dietary Supplement), placebo (Dietary Supplement) to Clomiphene Citrate (Drug), Myo-Inositol + Levomefolic acid (Dietary Supplement), placebo (Dietary Supplement)
    • Collaborators: 1 to 2
    v10
  5. Primary and study completion dates: Dec 2022 to Sep 2023
    • Start date: Dec 2020 to Sep 2021
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary and study completion dates: Apr 2020 to Dec 2022
    • Start date: Nov 2019 to Dec 2020
    v8
  2. Re-verified, no change to tracked fieldsv7
  3. Start date: Nov 2018 to Nov 2019v6
  4. Start date: Jul 2018 to Nov 2018v5
  5. Start date: Feb 2018 to Jul 2018v4
  6. Start date: Sep 2017 to Feb 2018v3
  7. Start date: May 2017 to Sep 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03059173
Lead Sponsor University Hospital, Lille
Collaborators: Ministry of Health, France, Laboratoires Besins International
Conditions
(from sponsor)		 Polycystic Ovary Syndrome, Reproductive Medicine
Related terms Polycystic Ovary Syndrome
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov