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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560065
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 20, 2012
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Inositol
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs