Clinical trial NCT03059173: Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
Official title: Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Reproductive Medicine
Keywords: Polycystic ovary syndrome
Reproductive medicine
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Laboratoires Besins International
First posted: 2017-02-23
Enrollment: 276
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Total resistance rate under CC for ovulation induction in patients with PCOS.
timeFrame: At each cycle during 4 months
Secondary outcomes:
measure: Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC
timeFrame: At each cycle during one year
measure: Rate of drop out
timeFrame: at each cycle during one year
measure: Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)
timeFrame: During one year
measure: Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study
timeFrame: At each cycle during one year
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU de Lille hôpital Jeanne de Flandre
Study officials:
affiliation: University Hospital, Lille
name: Goeffrey Robin, MD
role: PRINCIPAL_INVESTIGATOR
References: