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

NCT02221154 | Terminated Phase 4 DMC

• 1 other identifier: CHD 096-13
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 4

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.

Conditions

Polycystic Ovary Syndrome

Keywords

in vitro fertilization; ovarian hyperstimulation; pregnancy

Outcome Measures

Primary Outcomes (1)

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

  3 month

Study Arms (2)

Inofolic®

EXPERIMENTAL

standard ovarian stimulation and Inofolic®

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

Gonadotropins;Folic Acid

ACTIVE COMPARATOR

standard ovarian stimulation without Inofolic®

Other: Gonadotropins; Folic Acid

Interventions

Inofolic® DIETARY_SUPPLEMENT

Inofolic®

Gonadotropins; Folic Acid OTHER

standard ovarian stimulation

Gonadotropins;Folic Acid; Inofolic®

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (4)

CHI de Créteil

Créteil, 94000, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CH de Saint Nazaire

Saint-Nazaire, 44606, France

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Gonadotropins; Folic Acid

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fabienne DELAY, PH

  CHD Vendée La Roche sur Yon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: November 1, 2014
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: June 16, 2017

Record last verified: 2016-07

Locations

FR (4)