Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
MYOPK
3 other identifiers
interventional
276
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2023
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
September 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 22, 2026
April 1, 2025
4 years
January 26, 2017
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At each cycle during 4 months
Secondary Outcomes (4)
Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC
At each cycle during one year
Rate of drop out
at each cycle during one year
Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)
During one year
Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study
At each cycle during one year
Study Arms (2)
Myo-Inositol + Levomefolic acid
EXPERIMENTALThe 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).
Placebo
PLACEBO COMPARATORThe control group will receive the standard therapy ( Clomiphene Citrate) and a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Ministry of Health, Francecollaborator
- Laboratoires Besins Internationalcollaborator
Study Sites (1)
CHU de Lille hôpital Jeanne de Flandre
Lille, France
Related Publications (1)
Rolland AL, Peigne M, Plouvier P, Dumont A, Catteau-Jonard S, Dewailly D. Could myo-inositol soft gel capsules outperform clomiphene in inducing ovulation? Results of a pilot study. Eur Rev Med Pharmacol Sci. 2017 Jun;21(2 Suppl):10-14.
PMID: 28724178RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Goeffrey Robin, MD
University Hospital, Lille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2017
First Posted
February 23, 2017
Study Start
September 12, 2023
Primary Completion (Estimated)
September 12, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 22, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share