Polycystic Ovary Syndrome, Reproductive Medicine
Conditions
Keywords
Polycystic ovary syndrome, Reproductive medicine
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.
Interventions
DIETARY_SUPPLEMENTMyo-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.
DRUGClomiphene 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_SUPPLEMENTplacebo
a placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
Sponsors
University Hospital, Lille
Ministry of Health, France
Laboratoires Besins International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total resistance rate under CC for ovulation induction in patients with PCOS. | 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. |
Secondary
| 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 | 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 |
Countries
France
Contacts
CONTACTGoeffrey ROBIN, MD
PRINCIPAL_INVESTIGATORGoeffrey Robin, MD
University Hospital, Lille
Outcome results
None listed