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

Infertility Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338844
• Other study ID #: MI_vs_DCI_Oo_q
• Status: Completed
• Phase: Phase 4
• First received: April 14, 2011
• Last updated: May 31, 2011

Study information

• Verified date: April 2011
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Infertility

Intervention

Dietary Supplement:
• Myo-inositol

• D-chito-Inositol

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan
Italy	Research Center for Reproductive Medicine Villa Mafalda	Roma
Italy	Agunco	Rome

Sponsors (3)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre	Research Center for Reproductive Medicine Villa Mafalda, San Raffaele University Hospital, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of morphologically mature oocytes
Primary	Total international units (IU) of recombinant FSH administrated
Primary	number of grade 1 embryos