Role of Myo-inositol and D-chiro-inositol on Oocyte Quality

May 31, 2011 updated by: AGUNCO Obstetrics and Gynecology Centre

A Prospective, Randomized, Double Blind, Study on the Clinical Efficacy Myo-inositol Versus D-chiro-inositol in Women Undergoing in Vitro Fertilization Embryo Transfer.

Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).

The hormonal control of multiple follicular growth and maturation is a critical part of ART procedures since it maximizes the yield of embryos to be transferred, thus increasing the cumulative pregnancy rate.

Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and highly effective treatment in order to improve oocyte quality in patients undergoing IVF. Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable predictor of oocyte quality. High MI concentration in the FF directly correlates with high oocyte and embryo quality.

Another stereoisomer of Inositol was successfully used into clinical practice D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in hyperglycemic PCOS patients.

In the present study we aim to compare MI versus DCI supplementation on oocyte quality of women undergoing IVF-ET

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Italy
      • Milan, Italy
        • San Raffaele Hospital
      • Roma, Italy
        • Research Center for Reproductive Medicine Villa Mafalda
      • Rome, Italy
        • AGUNCO

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

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women undergoing IVF treatments
  • Body mass index <28
  • FSH <10IU/L
  • Normal uterine cavity, anatomy and functions

Exclusion Criteria:

  • PCOS
  • Stage III or IV endometriosis
  • Premature ovarian failure
  • Poor responder

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-Chiro-inositol
Patients will receive 1.2g/day of D-chiro-inositol
Dietary supplement: D-chito-Inositol
Active Comparator: Myo-inositol
Patients will receive 4g/day of myo-inositol
Dietary supplement: Myo-inositol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
number of morphologically mature oocytes
Total international units (IU) of recombinant FSH administrated
number of grade 1 embryos

Collaborators and Investigators

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

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Collaborators

San Raffaele University Hospital, Italy
Research Center for Reproductive Medicine Villa Mafalda

Investigators

  • Principal Investigator: Gianfranco Carlomagno, Ph.D., AGUNCO Obstetrics and Gynecology Centre
  • Principal Investigator: Vittorio Unfer, M.D., AGUNCO Obstetrics and Gynecology Centre
  • Principal Investigator: Franco Lisi, M.D., Research Center for Reproductive Medicine
  • Principal Investigator: Enrico Papaleo, M.D., San Raffaele Hospital
  • Principal Investigator: Scott Roseff, MD, The Palm Beach Center for Reproductive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI_vs_DCI_Oo_q

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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