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CompletedNCT01560065Updated Mar 22, 2012

Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing In Vitro Fertilization Cycles

A Phase 4 interventional study of myo-inositol + folic acid and myo-inositol + folic acid in Sperm Quality and Oligoasthenospermia, sponsored by AGUNCO Obstetrics and Gynecology Centre. Completed at 1 site in Italy. Open to male participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-03-22.

Sponsored by AGUNCO Obstetrics and Gynecology Centre · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules is higher than in serum and it was increasing during the movement through the epididymis and the deferent duct. In the present study, the role of myo-inositol has been investigated as a possible antioxidant agent for the systemic treatment of male infertility and the improvement of the sperm's quality.

Samples of seminal fluid were obtained from two groups of patients undergoing to a IVF cycle: healthy subjects and subjects with oligoasthenospermia (OA, \< 15 mil/ml). The collected samples were submitted to optic microscopy in order to evaluate semen's volume, spermatozoa's number and motility, during the initial semen analysis and after density gradient separation method; these parameters were evaluated before and after the administration of 4000mg/die of myo-inositol associated to 400 µg of folic acid for three months.

These values were compared with samples of seminal fluid of healthy patients undergoing to a IVF cycle for a female cause of infertility (control group).

02

Conditions studied

  • Sperm Quality
  • Oligoasthenospermia
03

In context

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male

Inclusion criteria

  • 3-5 days of sexual abstinence

Exclusion criteria

Exclusion Criteria:

  • systemic and endocrine diseases
  • genital infections
  • history of cryptorchidism or varicocele
  • microorchidism
  • hormonal treatment in the last six months
  • alcohol intake, cigarette smoke and/or drug abuse
05

Study design

Phase
Phase 4

Study arms

  • Other
    Normospermic patients

    Dietary Supplement: myo-inositol + folic acid

  • Other
    Oligoasthenospermic patients

    Dietary Supplement: myo-inositol + folic acid

  • No intervention
    Control

Interventions

  • Dietary supplementmyo-inositol + folic acid

    4000mg myo-inositol + 400 µg folic acid

  • Dietary supplementmyo-inositol + folic acid

    4000mg myo-inositol + 400 µg folic acid

06

What researchers measure

Primary outcomes

  1. Semen volume

  2. Spermatozoa count

  3. Spermatozoa progressive motility

  4. Number of spermatozoa after density gradient separation method

07

Study locations

1 site
  • University of Catania - Department of Surgery - Section of Obstetrics and Gynecology -Center of Physiopathology of Reproduction
    Catania, Italy
08

References and documents

Publications

  • Colone M, Marelli G, Unfer V, Bozzuto G, Molinari A, Stringaro A. Inositol activity in oligoasthenoteratospermia--an in vitro study. Eur Rev Med Pharmacol Sci. 2010 Oct;14(10):891-6. PubMed 21222378 ↗
  • Hinton BT, White RW, Setchell BP. Concentrations of myo-inositol in the luminal fluid of the mammalian testis and epididymis. J Reprod Fertil. 1980 Mar;58(2):395-9. doi: 10.1530/jrf.0.0580395. PubMed 7431272 ↗
  • de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5. PubMed 35506389 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01560065
Lead sponsor
AGUNCO Obstetrics and Gynecology Centre
Responsible party
Sponsor
First posted
Mar 22, 2012
Last update
Mar 22, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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