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

April 18, 2024 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • CHU de Lille hôpital Jeanne de Flandre
        • Contact:
          • Geoffroy Robin, MD, PhD
        • Principal Investigator:
          • Geoffroy Robin, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At each cycle during 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At each cycle during one year
Rate of drop out
Time Frame: at each cycle during one year
at each cycle during one year
Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)
Time Frame: During one year
During one year
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
At each cycle during one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France
Laboratoires Besins International

Investigators

  • Principal Investigator: Goeffrey Robin, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Estimated)

September 12, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_68
  • 2016-A01246-45 (Other Identifier: ID-RCB number, ANSM)
  • PHRC_N_15-0116 (Other Identifier: PHRC number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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