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

Sperm Quality Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560065
• Other study ID #: MI_IVF
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2012
• Last updated: March 21, 2012

Study information

• Verified date: January 2012
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Oligoasthenospermia
• Sperm Quality

Intervention

Dietary Supplement:
• myo-inositol + folic acid
4000mg myo-inositol + 400 µg folic acid
• myo-inositol + folic acid
4000mg myo-inositol + 400 µg folic acid

Locations

Country	Name	City	State
Italy	University of Catania - Department of Surgery - Section of Obstetrics and Gynecology -Center of Physiopathology of Reproduction	Catania

Sponsors (1)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semen volume
Primary	Spermatozoa count
Primary	Spermatozoa progressive motility
Primary	Number of spermatozoa after density gradient separation method