NCT01338844

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
Last Updated

June 1, 2011

Status Verified

April 1, 2011

First QC Date

April 14, 2011

Last Update Submit

May 31, 2011

Conditions

Infertility

Keywords

Poor oocyte qualityIVF failure

Outcome Measures

Primary Outcomes (3)

  • number of morphologically mature oocytes

  • Total international units (IU) of recombinant FSH administrated

  • number of grade 1 embryos

Study Arms (2)

D-Chiro-inositol

EXPERIMENTAL

Patients will receive 1.2g/day of D-chiro-inositol

Dietary Supplement: D-chito-Inositol

Myo-inositol

ACTIVE COMPARATOR

Patients will receive 4g/day of myo-inositol

Dietary Supplement: Myo-inositol

Interventions

Myo-inositolDIETARY_SUPPLEMENT
Myo-inositol
D-chito-InositolDIETARY_SUPPLEMENT
D-Chiro-inositol

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women undergoing IVF treatments
  • Body mass index \<28
  • FSH \<10IU/L
  • Normal uterine cavity, anatomy and functions

You may not qualify if:

  • PCOS
  • Stage III or IV endometriosis
  • Premature ovarian failure
  • Poor responder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

San Raffaele Hospital

Milan, Italy

Location

Research Center for Reproductive Medicine Villa Mafalda

Roma, Italy

Location

Agunco

Rome, Italy

Location

Related 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. doi: 10.1093/humrep/17.6.1591.

    PMID: 12042283BACKGROUND

  • 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.

    PMID: 21463230BACKGROUND

  • 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.

    PMID: 20712264BACKGROUND

  • 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.

    PMID: 19800728BACKGROUND

  • 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.

    PMID: 18462730BACKGROUND

  • 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.

    PMID: 10219066BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Inositol

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 20, 2011

Last Updated

June 1, 2011

Record last verified: 2011-04

Locations

IT(3)