Myo-inositol on Human Semen Parameters

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Asthenozoospermia, Oligospermia

Intervention / Treatment
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* Dietary Supplement: Myo-inositol normospermic
* Dietary Supplement: Myo-inositol OAT
* Dietary Supplement: Folic Acid normospermic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing to IVF cycle OAT Exclusion Criteria: No undergoing to IVF cycle

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Myo-inositol normospermic<br>29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid | Dietary Supplement: Myo-inositol normospermic<br>* 4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.<br>|
| Active Comparator: Myo-inositol OAT<br>13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid | Dietary Supplement: Myo-inositol OAT<br>* 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<br>|
| Placebo Comparator: Folic acid normospermic<br>20 normospermic patients treated with 400 µg of folic acid | Dietary Supplement: Folic Acid normospermic<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm concentration |  | after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Myo-inositol, oligoasthenoteratospermia, semen parameters