Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01560065
Other study ID # MI_IVF
Secondary ID
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
Est. completion date
Est. primary completion date
Accepts healthy volunteers
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


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06353880 - Obesity With Sperm Quality in Men With Fertility Need
Completed NCT01091220 - Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers Phase 1