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

Centre Hospitalier Departemental Vendee

Status and phase: Terminated; Phase 4

Conditions: Polycystic Ovary Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02221154

CHD 096-13

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Inofolic®

Experimental group

Description:

standard ovarian stimulation and Inofolic®

Treatment:

Dietary Supplement: Inofolic®

Other: Gonadotropins; Folic Acid

Gonadotropins;Folic Acid

Active Comparator group

Description:

standard ovarian stimulation without Inofolic®

Treatment:

Other: Gonadotropins; Folic Acid