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OpenTrials
Completed

NCT Number: NCT01828710

Myo-inositol on Human Semen Parameters

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.

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Key information

Conditions

Asthenozoospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Oligospermia Urogenital Diseases

Age range

25 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Physiopathology of Reproduction

Catania, CT, 95010, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Undergoing to IVF cycle OAT

Exclusion criteria

No undergoing to IVF cycle

Treatment and study plan

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.

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.

Primary outcomes

  1. sperm concentration

    Time frame: after 3 months

Sponsors and collaborators

Lead sponsor

AGUNCO Obstetrics and Gynecology Centre

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2013
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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