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

Istituto di Ricovera e Cura a Carattere Scientifico, San Raffaele Hospital

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

History of Changes

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:

MedlinePlus related topics: Infertility

Drug Information available for: Inositol

U.S. FDA Resources

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

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

Istituto di Ricovera e Cura a Carattere Scientifico, San Raffaele Hospital

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:

Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6.

Unfer V, Raffone E, Rizzo P, Buffo S. Effect of a supplementation with myo-inositol plus melatonin on oocyte quality in women who failed to conceive in previous in vitro fertilization cycles for poor oocyte quality: a prospective, longitudinal, cohort study. Gynecol Endocrinol. 2011 Apr 5; [Epub ahead of print]

Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.

Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. Epub 2009 Oct 2. Review.

Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-4. Epub 2008 May 7.

Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20.

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 May 23, 2013

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