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

NCT01560065 | Completed Phase 4

• 1 other identifier: MI_IVF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sperm Quality; Oligoasthenospermia

Outcome Measures

Primary Outcomes (4)

• Semen volume

• Spermatozoa count

• Spermatozoa progressive motility

• Number of spermatozoa after density gradient separation method

Study Arms (3)

Normospermic patients

OTHER

Dietary Supplement: myo-inositol + folic acid

Oligoasthenospermic patients

OTHER

Dietary Supplement: myo-inositol + folic acid

Control

NO INTERVENTION

Interventions

myo-inositol + folic acid DIETARY_SUPPLEMENT

4000mg myo-inositol + 400 µg folic acid

Normospermic patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Age Groups: Adult (18-64)

You may qualify if:

• days of sexual abstinence

You may not qualify if:

• 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

Sponsors & Collaborators

• AGUNCO Obstetrics and Gynecology Centre: lead

Study Sites (1)

University of Catania - Department of Surgery - Section of Obstetrics and Gynecology -Center of Physiopathology of Reproduction

Catania, Italy

Location

Related Publications (3)

• 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.

  PMID: 21222378 BACKGROUND

• 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.

  PMID: 7431272 BACKGROUND

• 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.

  PMID: 35506389 DERIVED

MeSH Terms

Interventions

Inositol; Folic Acid

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Last Updated: March 22, 2012

Record last verified: 2012-01

Locations

IT (1)