Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
Phase 4
Terminated
- Conditions
- Polycystic Ovary Syndrome
- Registration Number
- NCT02221154
- Lead Sponsor
- Centre Hospitalier Departemental Vendee
- Brief Summary
The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.
The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 49
Inclusion Criteria
- Patients PCOS (Rotterdam ESHRE / ASRM criteria)
Combination of at least two of the following three criteria:
- Cycle disorder
- Clinical hyperandrogenism and / or biological
- Account antral follicles> 24
- Age ≤ 18 ≤ 38 years
- BMI <35 kg / m²
- Able to understand the protocol and signed informed consent
Exclusion Criteria
- Patients not having the Rotterdam criteria
- Patients> 38 years and / or BMI> 35 kg / m²
- Woman enjoying a measure of legal protection
- Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid, glycerol, gelatin, coloring E171)
- Participation in another interventional biomedical research with treatment administered may disrupt ovarian stimulation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations 3 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
CHI de Créteil
🇫🇷Créteil, France
CHD Vendée
🇫🇷La Roche sur Yon, France
CHU de Nantes
🇫🇷Nantes, France
CH de Saint Nazaire
🇫🇷Saint Nazaire, France
CHI de Créteil🇫🇷Créteil, France