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Myo-inositol on Human Semen Parameters

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ClinicalTrials.gov Identifier: NCT01828710
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre

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.


Condition or disease Intervention/treatment Phase
Asthenozoospermia Oligospermia Dietary Supplement: Myo-inositol normospermic Dietary Supplement: Myo-inositol OAT Dietary Supplement: Folic Acid normospermic Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing IVF Cycles
Study Start Date : August 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Folic Acid

Arm Intervention/treatment
Sham Comparator: Myo-inositol normospermic
29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid
Dietary Supplement: Myo-inositol normospermic
4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.

Active Comparator: Myo-inositol OAT
13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid
Dietary Supplement: Myo-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

Placebo Comparator: Folic acid normospermic
20 normospermic patients treated with 400 µg of folic acid
Dietary Supplement: Folic 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.




Primary Outcome Measures :
  1. sperm concentration [ Time Frame: after 3 months ]


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Undergoing to IVF cycle OAT

Exclusion Criteria:

No undergoing to IVF cycle


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828710


Locations
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Italy
Centre of Physiopathology of Reproduction
Catania, CT, Italy, 95010
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
Investigators
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Principal Investigator: Marco Palumbo, M.D. University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of Reproduction
Study Director: Gianfranco Carlomagno, Ph.D. A.G.Un.Co. Obstetrics and gynaecology center

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Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT01828710     History of Changes
Other Study ID Numbers: INO-2103-GC
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
Myo-inositol
oligoasthenoteratospermia
semen parameters
IVF

Additional relevant MeSH terms:
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Inositol
Oligospermia
Asthenozoospermia
Infertility, Male
Infertility
Genital Diseases, Male
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs