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Myo-inositol on Human Semen Parameters

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01828710
Enrollment
62
Registered
2013-04-11
Start date
2012-08-31
Completion date
2012-11-30
Last updated
2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthenozoospermia, Oligospermia

Keywords

Myo-inositol, oligoasthenoteratospermia, semen parameters, IVF

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTMyo-inositol normospermic

4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.

DIETARY_SUPPLEMENTMyo-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

DIETARY_SUPPLEMENTFolic 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.

Sponsors

AGUNCO Obstetrics and Gynecology Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Undergoing to IVF cycle OAT

Exclusion criteria

No undergoing to IVF cycle

Design outcomes

Primary

MeasureTime frame
sperm concentrationafter 3 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026