Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)

Polycystic Ovary Syndrome Clinical Trial

— FIV-INOPK  

Official title:

Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02221154
• Other study ID #: CHD 096-13
• Status: Terminated
• Phase: Phase 4
• First received: August 18, 2014
• Last updated: June 15, 2017
• Start date: November 2014
• Est. completion date: May 22, 2017

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Inofolic®

Other:
• Gonadotropins; Folic Acid
standard ovarian stimulation

Locations

Country	Name	City	State
France	CHI de Créteil	Créteil
France	CHD Vendée	La Roche sur Yon
France	CHU de Nantes	Nantes
France	CH de Saint Nazaire	Saint Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations		3 month