Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorUniversity Hospital, Lille
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Myo-Inositol + Levomefolic acid
Dietary supplementDietary 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
DrugClomiphene 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
Dietary supplementa placebo containing only 0.736 mg of 5-MTHF, glucosamine salts
Treatment groups
276 Participants
are divided into 2 treatment groupsGroup A: Myo-Inositol + Levomefolic acidExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
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.
Time frame
At each cycle during 4 monthsSecondary outcomes
1
Rate of responders (i.e., 100% cycles with ovulation and/or occurrence of a pregnancy) at doses of 50 and 100mg of CC
Time frame
At each cycle during one year2
Rate of drop out
Time frame
at each cycle during one year3
Cumulative incidence of clinical pregnancy (cardiac activity on ultrasound at 6 weeks of amenorrhea)
Time frame
During one year4
Rate of patients switched to a 2nd line treatment with exogenous gonadotropins over the whole period of the study
Time frame
At each cycle during one yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Ministry of Health, France
Collaborator
Laboratoires Besins International
Collaborator
Source ClinicalTrials.gov