Myo-inositol on Human Semen Parameters
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|ClinicalTrials.gov Identifier: NCT01828710|
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthenozoospermia Oligospermia||Dietary Supplement: Myo-inositol normospermic Dietary Supplement: Myo-inositol OAT Dietary Supplement: Folic Acid normospermic||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing IVF Cycles|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Sham Comparator: Myo-inositol normospermic
29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid
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.
Active Comparator: Myo-inositol OAT
13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid
Dietary Supplement: 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
Placebo Comparator: Folic acid normospermic
20 normospermic patients treated with 400 µg of folic acid
Dietary Supplement: 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.
- sperm concentration [ Time Frame: after 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828710
|Centre of Physiopathology of Reproduction|
|Catania, CT, Italy, 95010|
|Principal Investigator:||Marco Palumbo, M.D.||University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of Reproduction|
|Study Director:||Gianfranco Carlomagno, Ph.D.||A.G.Un.Co. Obstetrics and gynaecology center|