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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 20, 2012
Last Updated Date	March 21, 2012
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2012)	Semen volume Spermatozoa count Spermatozoa progressive motility Number of spermatozoa after density gradient separation method
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01560065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing In Vitro Fertilization Cycles
Official Title ^ICMJE	Not Provided
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Sperm Quality Oligoasthenospermia
Intervention ^ICMJE	Dietary Supplement: myo-inositol + folic acid 4000mg myo-inositol + 400 µg folic acid
Study Arm (s)	Normospermic patients Intervention: Dietary Supplement: myo-inositol + folic acid Oligoasthenospermic patients Intervention: Dietary Supplement: myo-inositol + folic acid No Intervention: Control
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01560065
Other Study ID Numbers ^ICMJE	MI_IVF
Has Data Monitoring Committee	Not Provided
Responsible Party	AGUNCO Obstetrics and Gynecology Centre
Study Sponsor ^ICMJE	AGUNCO Obstetrics and Gynecology Centre
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AGUNCO Obstetrics and Gynecology Centre
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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