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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myo-inositol normospermic | Sham Comparator | 29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid |
|
| Myo-inositol OAT | Active Comparator | 13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid |
|
| Folic acid normospermic | Placebo Comparator | 20 normospermic patients treated with 400 µg of folic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myo-inositol normospermic | Dietary Supplement | 4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| sperm concentration | after 3 months |
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Inclusion Criteria:
Undergoing to IVF cycle OAT
Exclusion Criteria:
No undergoing to IVF cycle
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| Name | Affiliation | Role |
|---|---|---|
| Marco Palumbo, M.D. | University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of Reproduction | Principal Investigator |
| Gianfranco Carlomagno, Ph.D. | A.G.Un.Co. Obstetrics and gynaecology center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Physiopathology of Reproduction | Catania | CT | 95010 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35506389 | Derived | 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. |
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| ID | Term |
|---|---|
| D053627 | Asthenozoospermia |
| D009845 | Oligospermia |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Myo-inositol OAT | Dietary Supplement | 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 | Dietary Supplement | 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. |
|
| D007246 |
| Infertility |
| D052801 | Male Urogenital Diseases |