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

NCT ID: NCT03059173

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2027-12-31

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.

Conditions

Polycystic Ovary Syndrome; Reproductive Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Myo-Inositol + Levomefolic acid

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Clomiphene Citrate

Intervention Type: DRUG

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

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DRUG

placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Myo + [6S]-5-MethylTetrahydrofolate(5-MTHF) ou Gynositol (R)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Laboratoires Besins International

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Goeffrey Robin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CHU de Lille hôpital Jeanne de Flandre

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Goeffrey ROBIN, MD

Role: CONTACT

goeffrey.robin@chru-lille.fr

320446252 ext. +33

Facility Contacts

Geoffroy Robin, MD, PhD

Role: primary

Other Identifiers

2016-A01246-45

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC_N_15-0116

Identifier Type: OTHER

Identifier Source: secondary_id

2015_68

Identifier Type: -

Identifier Source: org_study_id