Informations générales (source: ClinicalTrials.gov)
Interest of Myo-inositol Supplementation in Women With Polycystic Ovarian Syndrome During Induction of Ovulation With Clomiphene Citrate (MYOPK)
Interventional
Phase 3
University Hospital, Lille (Voir sur ClinicalTrials)
septembre 2023
décembre 2027
29 juin 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Lille hôpital Jeanne de Flandre - Lille - France | Geoffroy Robin, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Femme
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
- 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
- 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.