Completed

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

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What is being tested

D-chiro-inositol

+ Myoinositol

Drug
Who is being recruted

Urogenital Diseases+11

+ Genital Diseases

+ Adnexal Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: February 2016
See protocol details

Summary

Principal SponsorBiosearch S.A.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleComparison 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
NCT03201601
Principal SponsorBiosearch S.A.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCystsEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGonadal DisordersInfertilityNeoplasmsOvarian CystsOvarian DiseasesPolycystic Ovary SyndromeFemale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
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.
6 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Experimental
Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers