Status:
TERMINATED
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
Lead Sponsor:
Centre Hospitalier Departemental Vendee
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-38 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2017
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT02221154
Start Date
November 1 2014
End Date
May 22 2017
Last Update
June 16 2017
Active Locations (4)
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1
CHI de Créteil
Créteil, France, 94000
2
CHD Vendée
La Roche-sur-Yon, France, 85925
3
CHU de Nantes
Nantes, France, 44093
4
CH de Saint Nazaire
Saint-Nazaire, France, 44606