Clinical Trials Directory

Trials / Completed

CompletedNCT01828710

Myo-inositol on Human Semen Parameters

Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing IVF Cycles

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
AGUNCO Obstetrics and Gynecology Centre · Academic / Other
Sex
Male
Age
25 Years – 65 Years
Healthy volunteers
Accepted

Summary

Many clinical evidences suggest that Myo-inositol plays a crucial role in human reproduction. Also, it was shown that Myo-inositol concentration in the seminiferous tubules was higher than in serum, and interestingly it was increasing through the epididymis and the deferent duct mining that sperm cell before ejaculation are stored in a "medium" highly enriched in myo-inositol. Starting from this evidences, the investigators hypothesized that myo-inositol may be a possible factor able to improve the semen parameters of samples used in in vitro fertilization cycles.

Detailed description

Samples of seminal fluid were obtained from two groups of patients undergoing to an IVF cycle: healthy normospermic subjects and subjects with oligoasthenoteratospermia (OAT, \< 15 mil/ml). Semen volume, spermatozoa number and motility were evaluated 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 (Inofolic lolipharma Rome) for three months. A third group of healthy normospermic subject were traded with 400 µg of folic acid for three months and was consider a control group.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTMyo-inositol normospermic4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.
DIETARY_SUPPLEMENTMyo-inositol OATB 13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months
DIETARY_SUPPLEMENTFolic Acid normospermicGroup C 20 normospermic patients treated with 400 µg of folic acid (kindly provided by Lo.Li. pharma s.r.l., Roma) for three months.

Timeline

Start date
2012-08-01
Primary completion
2012-11-01
Completion
2012-11-01
First posted
2013-04-11
Last updated
2022-07-25

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01828710. Inclusion in this directory is not an endorsement.