Clinical trial NCT01338844: Role of Myo-inositol and D-chiro-inositol on Oocyte Quality
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Poor oocyte quality
IVF failure
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
Collaborators: name: Research Center for Reproductive Medicine Villa Mafalda
name: San Raffaele University Hospital, Italy
First posted: 2011-04-20
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility 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

Primary outcomes:
measure: number of morphologically mature oocytes
measure: Total international units (IU) of recombinant FSH administrated
measure: number of grade 1 embryos
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Roma
country: Italy
facility: Research Center for Reproductive Medicine Villa Mafalda
city: Rome
country: Italy
facility: Agunco
Study officials:
affiliation: AGUNCO Obstetrics and Gynecology Centre
name: Gianfranco Carlomagno, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: AGUNCO Obstetrics and Gynecology Centre
name: Vittorio Unfer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Reproductive Medicine
name: Franco Lisi, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: San Raffaele Hospital
name: Enrico Papaleo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Palm Beach Center for Reproductive Medicine
name: Scott Roseff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
citation: 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.
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. doi: 10.1056/NEJM199904293401703.