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

Last updated: January 9, 2019
Sponsor: Biosearch S.A.
Overall Status: Completed

Phase

2/3

Condition

Reproductive Health

Infertility

Polycystic Ovarian Syndrome

Treatment

N/A

Clinical Study ID

NCT03201601
C015
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Contraindication to perform techniques of assisted reproduction or stimulation ofovulation.

  • 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.

Study Design

Total Participants: 60
Study Start date:
February 01, 2016
Estimated Completion Date:
May 05, 2017

Study Description

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.