Polycystic Ovary Syndrome
Conditions
Keywords
in vitro fertilization, ovarian hyperstimulation, pregnancy
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.
Interventions
DIETARY_SUPPLEMENTInofolic®
OTHERGonadotropins; Folic Acid
standard ovarian stimulation
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations | 3 month |
Countries
France
Outcome results
None listed