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
• Interventions: Dietary Supplement: Inofolic®; Other: Gonadotropins; Folic Acid

• 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

Study Timeline

• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Study Start: 2014-11
• Status Verified: 2016-07
• Primary Completion: 2017-05-22
• Study Completion: 2017-05-22
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

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

Arm && Interventions

Group	Intervention	Description
Inofolic®	Gonadotropins; Folic Acid	standard ovarian stimulation and Inofolic®
Inofolic®	Inofolic®	standard ovarian stimulation and Inofolic®
Gonadotropins;Folic Acid	Gonadotropins; Folic Acid	standard ovarian stimulation without Inofolic®

Primary Outcome Measures

Name	Time	Method
Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations	3 month

Trial Locations

Locations (4)

CHD Vendée; 🇫🇷 La Roche sur Yon, France

CHI de Créteil; 🇫🇷 Créteil, France

CHU de Nantes; 🇫🇷 Nantes, France

CH de Saint Nazaire; 🇫🇷 Saint Nazaire, France