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

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ClinicalTrials.gov Identifier: NCT01338844

Recruitment Status : Completed

First Posted : April 20, 2011

Last Update Posted : June 1, 2011

Sponsor:

Collaborators:

Research Center for Reproductive Medicine Villa Mafalda

San Raffaele University Hospital, Italy

Information provided by:

AGUNCO Obstetrics and Gynecology Centre

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Infertility	Dietary Supplement: Myo-inositol Dietary Supplement: D-chito-Inositol	Phase 4

Study Design


Study Type :	Interventional (Clinical Trial)
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 the National Library of Medicine

Drug Information available for: Inositol

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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:

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 Nov;27(11):857-61. doi: 10.3109/09513590.2011.564687. Epub 2011 Apr 5.

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. doi: 10.1016/j.ejogrb.2009.09.008. 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. doi: 10.1016/j.fertnstert.2008.01.088. 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
First Posted:	April 20, 2011 Key Record Dates
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

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