Evaluation of the Mixture Myoinositol:D-chiro-inositol 3.6:1 in Women With Polycystic Ovary Syndrome

Phase 3CompletedNCT03201601

Biosearch S.A.60 enrolled

Overview

The aim of the present study is to evaluate the effect of increasing the proportion of D-chiro-inositol (DCI) in a combination with myo-inositol (MYO) in improving fertility in women with polycystic ovarian syndrome (PCOS). Sixty women diagnosed with PCOS will randomly take twice a day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol or capsules containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.

Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy in women of childbearing age. It affects 4-8% of the population and of them, approximately 74% present anovulatory cycles and, therefore, fertility problems. Both myo-inositol and D-chiro-inositol are 2 natural substances that have been shown to improve ovarian function and metabolism in women with polycystic ovarian syndrome. The aim of the present study is to compare the effect of 2 ratios of myo-inositol /D-chiro-inositol on parameters related to the fertility of women with PCOS. It is a multicenter, controlled, randomized, double-blind, parallel-group, 12-week clinical trial which will be conducted in 13 public and private hospitals from Spain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Polycystic Ovarian Syndrome Infertility

Interventions

D-chiro-inositolDRUG

Each participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks.

MyoinositolDRUG

Each participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Being diagnosed with PCOS according to Rotterdam criteria. * Being in in vitro fertilization treatment. * Body mass index less than 30 kg/m2. * Accept freely to participate in the study and sign the informed consent document. Exclusion Criteria: * Contraindication to perform techniques of assisted reproduction or stimulation of ovulation. * Advanced state of endometriosis (III or IV). * Classified as poor responder in fertility treatment. * Premature ovarian failure. * Severe male factor (cryptozoospermia). * Few expectations of compliance and/or collaboration.

Outcomes

Primary Outcomes

Pregnancy rate

Number of pregnancies

Time frame: 12 weeks

Secondary Outcomes

Mature MII oocytes

Number of mature MII oocytes

Time frame: 12 weeks

IM/VG oocytes

Number of IM/VG oocytes

Time frame: 12 weeks

Grade I, II, III embryos

Number of embryos of degree I, II, III

Time frame: 12 weeks

Days of stimulation

Time frame: 12 weeks

Gestational sacs

Number of gestational sacs

Time frame: 12 weeks

Transferred embryos

Number of embryos transferred

Time frame: 12 weeks

Total testosterone

Total testosterone levels

Time frame: 12 weeks

Glucose

Glucose levels

Time frame: 12 weeks

Insulin

Insulin levels

Time frame: 12 weeks

Data from ClinicalTrials.gov

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