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

Primary Purpose

Polycystic Ovary Syndrome, Reproductive Medicine

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Myo-Inositol + Levomefolic acid
Clomiphene Citrate
placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, Reproductive medicine

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Myo-Inositol + Levomefolic acid

    Placebo

    Arm Description

    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).

    The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC
    Rate of drop out
    Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)
    Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study

    Full Information

    First Posted
    January 26, 2017
    Last Updated
    January 27, 2022
    Sponsor
    University Hospital, Lille
    Collaborators
    Ministry of Health, France, Laboratoires Besins International
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03059173
    Brief Title
    Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
    Acronym
    MYOPK
    Official Title
    Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille
    Collaborators
    Ministry of Health, France, Laboratoires Besins International

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome, Reproductive Medicine
    Keywords
    Polycystic ovary syndrome, Reproductive medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    276 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Myo-Inositol + Levomefolic acid
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Myo-Inositol + Levomefolic acid
    Other Intervention Name(s)
    Myo + [6S]-5-MethylTetrahydrofolate(5-MTHF) ou Gynositol (R)
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Clomiphene Citrate
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
    Primary Outcome Measure Information:
    Title
    Total resistance rate under CC for ovulation induction in patients with PCOS.
    Description
    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 Outcome Measure Information:
    Title
    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
    Title
    Rate of drop out
    Time Frame
    at each cycle during one year
    Title
    Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)
    Time Frame
    During one year
    Title
    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

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Woman of childbearing age
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Goeffrey ROBIN, MD
    Phone
    320446252
    Ext
    +33
    Email
    goeffrey.robin@chru-lille.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Goeffrey Robin, MD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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