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OpenTrials
Completed

NCT Number: NCT01560065

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

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).

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Key information

Conditions

Sperm Quality Oligoasthenospermia

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

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

Catania, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myo-inositol + Folic acid

Dietary Supplement

4000mg myo-inositol + 400 µg folic acid

Primary outcomes

  1. Semen volume

  2. Spermatozoa count

  3. Spermatozoa progressive motility

  4. Number of spermatozoa after density gradient separation method

Sponsors and collaborators

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre

Other

Registry information

Important dates

First posted
Mar 22, 2012
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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