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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03059173
Recruitment Status : Not yet recruiting
First Posted : February 23, 2017
Last Update Posted : February 10, 2022
Sponsor:
Collaborators:
Ministry of Health, France
Laboratoires Besins International
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Reproductive Medicine Dietary Supplement: Myo-Inositol + Levomefolic acid Drug: Clomiphene Citrate Dietary Supplement: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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 Name: Myo + [6S]-5-MethylTetrahydrofolate(5-MTHF) ou Gynositol (R)

Drug: Clomiphene 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.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Woman of childbearing age
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059173


Contacts
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Contact: Goeffrey ROBIN, MD 320446252 ext +33 goeffrey.robin@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Laboratoires Besins International
Investigators
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Principal Investigator: Goeffrey Robin, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03059173    
Other Study ID Numbers: 2015_68
2016-A01246-45 ( Other Identifier: ID-RCB number, ANSM )
PHRC_N_15-0116 ( Other Identifier: PHRC number )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Polycystic ovary syndrome
Reproductive medicine
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Inositol
Clomiphene
Enclomiphene
Zuclomiphene
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Vitamin B Complex
Vitamins
Micronutrients