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

Polycystic Ovary Syndrome Clinical Trial

— MYOPK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03059173
• Other study ID #: 2015_68
• Secondary ID: 2016-A01246-45PH
• Status: Recruiting
• Phase: Phase 3
• Start date: September 12, 2023
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: University Hospital, Lille
• Contact: Goeffrey ROBIN, MD
• Phone: 320446252
• Email: goeffrey.robin[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: December 2027
• Est. primary completion date: September 12, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Reproductive Medicine
• Syndrome

Intervention

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.

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

Locations

Country	Name	City	State
France	CHU de Lille hôpital Jeanne de Flandre	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Laboratoires Besins International, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of drop out		at each cycle during one year
Secondary	Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)		During one year
Secondary	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