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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-05-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Inofolic®

standard ovarian stimulation and Inofolic®

Group Type EXPERIMENTAL

Inofolic®

Intervention Type DIETARY_SUPPLEMENT

Gonadotropins; Folic Acid

Intervention Type OTHER

standard ovarian stimulation

Gonadotropins;Folic Acid

standard ovarian stimulation without Inofolic®

Group Type ACTIVE_COMPARATOR

Gonadotropins; Folic Acid

Intervention Type OTHER

standard ovarian stimulation

Interventions

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Inofolic®

Intervention Type DIETARY_SUPPLEMENT

Gonadotropins; Folic Acid

standard ovarian stimulation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No