Role of Myo-inositol and D-chiro-inositol on Oocyte Quality
NCT ID: NCT01338844
Last Updated: 2011-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
INTERVENTIONAL
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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D-Chiro-inositol
Patients will receive 1.2g/day of D-chiro-inositol
D-chito-Inositol
Myo-inositol
Patients will receive 4g/day of myo-inositol
Myo-inositol
Interventions
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Myo-inositol
D-chito-Inositol
Eligibility Criteria
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Inclusion Criteria
* Body mass index \<28
* FSH \<10IU/L
* Normal uterine cavity, anatomy and functions
Exclusion Criteria
* Stage III or IV endometriosis
* Premature ovarian failure
* Poor responder
25 Years
45 Years
FEMALE
No
Sponsors
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Research Center for Reproductive Medicine Villa Mafalda
UNKNOWN
San Raffaele University Hospital, Italy
OTHER
AGUNCO Obstetrics and Gynecology Centre
OTHER
Principal Investigators
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Gianfranco Carlomagno, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
AGUNCO Obstetrics and Gynecology Centre
Vittorio Unfer, M.D.
Role: PRINCIPAL_INVESTIGATOR
AGUNCO Obstetrics and Gynecology Centre
Franco Lisi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Research Center for Reproductive Medicine
Enrico Papaleo, M.D.
Role: PRINCIPAL_INVESTIGATOR
San Raffaele Hospital
Scott Roseff, MD
Role: PRINCIPAL_INVESTIGATOR
The Palm Beach Center for Reproductive Medicine
Locations
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San Raffaele Hospital
Milan, , Italy
Research Center for Reproductive Medicine Villa Mafalda
Roma, , Italy
Agunco
Rome, , Italy
Countries
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References
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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. doi: 10.1093/humrep/17.6.1591.
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.
Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. RETRACTED: Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-1754. 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. doi: 10.1056/NEJM199904293401703.
Other Identifiers
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MI_vs_DCI_Oo_q
Identifier Type: -
Identifier Source: org_study_id
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