Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

December 5, 2018 updated by: Universitair Ziekenhuis Brussel

Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial

A randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower testosterone levels and improve clinical outcomes in hyperandrogenic PCOS patients undergoing ART

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 18-40 years
  • PCOS phenotypes A, B and C
  • Signed informed consent

Exclusion Criteria:

  • Other relevant endocrine disorders
  • Contraindications to the use of gonadotropins
  • Endometriosis grade 3-4
  • BMI > 35

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: Myo-inositol
Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology)
Drug: Myo-inositol
Myo-inositol and Folic acid daily
Other: Folic acid
Folic acid 0.4 mg daily during 12 weeks before start of ART
Drug: Folic Acid
Folic Acid daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum testosterone level after 12 weeks of administration of Myo-Inositol
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol
Time Frame: 2 years
2 years
Number of mature oocytes
Time Frame: 2 years
2 years
Embryo quality
Time Frame: 2 years
Day 3 embryos will be classified as transferable or cryopreservable/ 'good-quality embryos' (GQE) according to the criteria described by Van Landuyt et al. (2013). Blastocysts will be categorized according to Gardner et al. (1998) and Gardner and Schoolcraft (1999).
2 years
Implantation rate (%)
Time Frame: 2 years
2 years
Clinical pregnancy rate (%)
Time Frame: 2 years
2 years
Live birth rate in fresh cycle
Time Frame: 2 years
2 years
Cumulative live birth rate after 1 cycle
Time Frame: 2 years
2 years
Ovarian Hyperstimulation Syndrome rate
Time Frame: 2 years
2 years
Consumption of gonadotrophins
Time Frame: 2 years
measurement in IU
2 years
Stimulation days
Time Frame: 2 years
measurement in days
2 years

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

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 (Actual)

September 1, 2018

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gynositol.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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