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

June 15, 2017 updated by: Centre Hospitalier Departemental Vendee

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94000
        • CHI de Créteil
      • La Roche sur Yon, France, 85925
        • CHD Vendee
      • Nantes, France, 44093
        • CHU de Nantes
      • Saint Nazaire, France, 44606
        • CH de SAINT NAZAIRE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inofolic®
standard ovarian stimulation and Inofolic®
Dietary supplement: Inofolic®
Other: Gonadotropins; Folic Acid
standard ovarian stimulation
Active Comparator: Gonadotropins;Folic Acid
standard ovarian stimulation without Inofolic®
Other: Gonadotropins; Folic Acid
standard ovarian stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Principal Investigator: Fabienne DELAY, PH, CHD Vendée La Roche sur Yon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

May 22, 2017

Study Completion (Actual)

May 22, 2017

Study Registration Dates

First Submitted

August 18, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 096-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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