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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01338844
First Posted: April 20, 2011
Last Update Posted: June 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Research Center for Reproductive Medicine Villa Mafalda
San Raffaele University Hospital, Italy
Information provided by:
AGUNCO Obstetrics and Gynecology Centre
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 14, 2011
First Posted: April 20, 2011
Last Update Posted: June 1, 2011
Last Verified: April 2011

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