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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier:
NCT01560065
First received: March 20, 2012
Last updated: March 21, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention Phase
Sperm Quality
Oligoasthenospermia
Dietary Supplement: myo-inositol + folic acid
Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by AGUNCO Obstetrics and Gynecology Centre:

Primary Outcome Measures:
  • Semen volume
  • Spermatozoa count
  • Spermatozoa progressive motility
  • Number of spermatozoa after density gradient separation method

Arms Assigned Interventions
Normospermic patients Dietary Supplement: myo-inositol + folic acid
4000mg myo-inositol + 400 µg folic acid
Oligoasthenospermic patients Dietary Supplement: myo-inositol + folic acid
4000mg myo-inositol + 400 µg folic acid
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Criteria

Inclusion Criteria:

  • 3-5 days of sexual abstinence

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01560065

Locations
Italy
University of Catania - Department of Surgery - Section of Obstetrics and Gynecology -Center of Physiopathology of Reproduction
Catania, Italy
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
  More Information

Publications:
Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01560065     History of Changes
Other Study ID Numbers: MI_IVF
Study First Received: March 20, 2012
Last Updated: March 21, 2012
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Inositol
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014