Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2012-08-31
2012-11-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Myo-inositol normospermic
29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid
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
13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid
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
20 normospermic patients treated with 400 µg of folic acid
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
65 Years
MALE
Yes
Sponsors
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AGUNCO Obstetrics and Gynecology Centre
OTHER
Responsible Party
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Principal Investigators
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Marco Palumbo, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of Reproduction
Gianfranco Carlomagno, Ph.D.
Role: STUDY_DIRECTOR
A.G.Un.Co. Obstetrics and gynaecology center
Locations
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Centre of Physiopathology of Reproduction
Catania, CT, Italy
Countries
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References
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de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.
Other Identifiers
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INO-2103-GC
Identifier Type: -
Identifier Source: org_study_id
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