NCT03201601

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

Comparison of the Effect of a Combination of Myoinositol:D-chiro-inositol With Low Proportion of DCI (40:1) Versus a Combination With a Higher Proportion of DCI (3.6:1) in the Oocyte Quality and Pregnancy Rates in Women With PCOS

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Biosearch S.A. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Polycystic Ovarian Syndrome
• Infertility

Interventions

Type	Name	Description
DRUG	D-chiro-inositol	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.
DRUG	Myoinositol	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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-05-01
• Completion: 2017-05-05
• First posted: 2017-06-28
• Last updated: 2019-01-10