- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Catania, Italy
- University of Catania - Department of Surgery - Section of Obstetrics and Gynecology -Center of Physiopathology of Reproduction
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
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Other: Normospermic patients
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4000mg myo-inositol + 400 µg folic acid
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Other: Oligoasthenospermic patients
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4000mg myo-inositol + 400 µg folic acid
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Semen volume
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Spermatozoa count
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Spermatozoa progressive motility
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Number of spermatozoa after density gradient separation method
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MI_IVF
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