An interventional study of Myo-inositol normospermic and Myo-inositol OAT in Asthenozoospermia and Oligospermia, sponsored by AGUNCO Obstetrics and Gynecology Centre. Completed at 1 site in Italy. Open to male participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by AGUNCO Obstetrics and Gynecology Centre · Not applicable, Interventional, and Screening
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.
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.
32 studies on the registry are indexed under Asthenozoospermia; 9 are open to participants now.
This study's enrollment of 62 is close to the median of 62 across 25 interventional studies indexed under Asthenozoospermia.
Browse Asthenozoospermia studies →AGUNCO Obstetrics and Gynecology Centre is the lead sponsor of 20 studies on the registry; none are open to participants now.
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Undergoing to IVF cycle OAT
Exclusion Criteria:
No undergoing to IVF cycle
29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid
Dietary Supplement: Myo-inositol normospermic
13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid
Dietary Supplement: Myo-inositol OAT
20 normospermic patients treated with 400 µg of folic acid
Dietary Supplement: Folic Acid normospermic
4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.
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
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
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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AGUNCO Obstetrics and Gynecology Centre