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

This study has been completed.
Sponsor:
Collaborators:
Research Center for Reproductive Medicine Villa Mafalda
San Raffaele University Hospital, Italy
Information provided by:
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01338844
First received: April 14, 2011
Last updated: May 31, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Infertility
Dietary Supplement: Myo-inositol
Dietary Supplement: D-chito-Inositol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Prospective, Randomized, Double Blind, Study on the Clinical Efficacy Myo-inositol Versus D-chiro-inositol in Women Undergoing in Vitro Fertilization Embryo Transfer.

Resource links provided by NLM:


Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

Primary Outcome Measures:
  • number of morphologically mature oocytes
  • Total international units (IU) of recombinant FSH administrated
  • number of grade 1 embryos

Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01338844

Locations
Italy
San Raffaele Hospital
Milan, Italy
Research Center for Reproductive Medicine Villa Mafalda
Roma, Italy
Agunco
Rome, Italy
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
Research Center for Reproductive Medicine Villa Mafalda
San Raffaele University Hospital, Italy
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01338844     History of Changes
Other Study ID Numbers: MI_vs_DCI_Oo_q
Study First Received: April 14, 2011
Last Updated: May 31, 2011
Health Authority: Italy: National Institute of Health

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
Poor oocyte quality
IVF failure

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Inositol
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014