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NCT01828710 Clinical Trial

Myo-inositol on Human Semen Parameters

Oligospermia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01828710
Other study ID # INO-2103-GC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2012
Est. completion date November 2012

Study information
Verified date July 2022
Source AGUNCO Obstetrics and Gynecology Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria: Undergoing to IVF cycle OAT Exclusion Criteria: No undergoing to IVF cycle

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Myo-inositol normospermic
4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.
• Myo-inositol OAT
B 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
• Folic Acid normospermic
Group C 20 normospermic patients treated with 400 µg of folic acid (kindly provided by Lo.Li. pharma s.r.l., Roma) for three months.

Locations
Country Name City State
Italy Centre of Physiopathology of Reproduction Catania CT

Sponsors (1)
Lead Sponsor Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary sperm concentration after 3 months
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