NCT03201601

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
Last Updated

January 10, 2019

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

June 27, 2017

Last Update Submit

January 9, 2019

Conditions

Polycystic Ovarian SyndromeInfertility

Keywords

Polycystic ovarian syndromeD-chiro-inositolFertility

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    Number of pregnancies

    12 weeks

Secondary Outcomes (9)

  • Mature MII oocytes

    12 weeks

  • IM/VG oocytes

    12 weeks

  • Grade I, II, III embryos

    12 weeks

  • Days of stimulation

    12 weeks

  • Gestational sacs

    12 weeks

  • +4 more secondary outcomes

Study Arms (2)

550 mg of MYO and 150 mg of DCI

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.

Drug: D-chiro-inositolDrug: Myoinositol

550 mg of MYO and 13.8 mg of DCI

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.

Drug: D-chiro-inositolDrug: Myoinositol

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.

Also known as: Cis-1,2,4-trans-3,5,6-cyclohexanehexol
550 mg of MYO and 13.8 mg of DCI550 mg of MYO and 150 mg of DCI
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.

Also known as: cis-1,2,3,5-trans-4,6-cyclohexanehexol
550 mg of MYO and 13.8 mg of DCI550 mg of MYO and 150 mg of DCI

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertility

Interventions

Inositol

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Nicolás Mendoza, MD, PhD

    Professor of Gynecology at the Faculty of Medicine of the University of Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2017

First Posted

June 28, 2017

Study Start

February 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 5, 2017

Last Updated

January 10, 2019

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share