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

Primary Purpose

Polycystic Ovary Syndrome

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Inofolic®
Gonadotropins; Folic Acid
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Polycystic Ovary Syndrome focused on measuring in vitro fertilization, ovarian hyperstimulation, pregnancy

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHI de Créteil
  • CHD Vendée
  • CHU de Nantes
  • CH de Saint Nazaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inofolic®

Gonadotropins;Folic Acid

Arm Description

standard ovarian stimulation and Inofolic®

standard ovarian stimulation without Inofolic®

Outcomes

Primary Outcome Measures

Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations

Secondary Outcome Measures

Full Information

First Posted
August 18, 2014
Last Updated
June 15, 2017
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT02221154
Brief Title
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
Acronym
FIV-INOPK
Official Title
Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 22, 2017 (Actual)
Study Completion Date
May 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
in vitro fertilization, ovarian hyperstimulation, pregnancy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inofolic®
Arm Type
Experimental
Arm Description
standard ovarian stimulation and Inofolic®
Arm Title
Gonadotropins;Folic Acid
Arm Type
Active Comparator
Arm Description
standard ovarian stimulation without Inofolic®
Intervention Type
Dietary Supplement
Intervention Name(s)
Inofolic®
Intervention Type
Other
Intervention Name(s)
Gonadotropins; Folic Acid
Intervention Description
standard ovarian stimulation
Primary Outcome Measure Information:
Title
Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations
Time Frame
3 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabienne DELAY, PH
Organizational Affiliation
CHD Vendée La Roche sur Yon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHI de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHD Vendée
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CH de Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44606
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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