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

January 9, 2019 updated by: Biosearch S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 550 mg of MYO and 150 mg of DCI
Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol.
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.
Other Names:
  • Cis-1,2,4-trans-3,5,6-cyclohexanehexol
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.
Other Names:
  • cis-1,2,3,5-trans-4,6-cyclohexanehexol
Active Comparator: 550 mg of MYO and 13.8 mg of DCI
Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.
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.
Other Names:
  • Cis-1,2,4-trans-3,5,6-cyclohexanehexol
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.
Other Names:
  • cis-1,2,3,5-trans-4,6-cyclohexanehexol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 12 weeks
Number of pregnancies
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mature MII oocytes
Time Frame: 12 weeks
Number of mature MII oocytes
12 weeks
IM/VG oocytes
Time Frame: 12 weeks
Number of IM/VG oocytes
12 weeks
Grade I, II, III embryos
Time Frame: 12 weeks
Number of embryos of degree I, II, III
12 weeks
Days of stimulation
Time Frame: 12 weeks
Days of stimulation
12 weeks
Gestational sacs
Time Frame: 12 weeks
Number of gestational sacs
12 weeks
Transferred embryos
Time Frame: 12 weeks
Number of embryos transferred
12 weeks
Total testosterone
Time Frame: 12 weeks
Total testosterone levels
12 weeks
Glucose
Time Frame: 12 weeks
Glucose levels
12 weeks
Insulin
Time Frame: 12 weeks
Insulin levels
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosearch S.A.

Investigators

  • Principal Investigator: Nicolás Mendoza, MD, PhD, Professor of Gynecology at the Faculty of Medicine of the University of Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 5, 2017

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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