Myo-inositol on Human Semen Parameters

NCT ID: NCT01828710

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-11-30

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.

Conditions

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Asthenozoospermia Oligospermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Myo-inositol normospermic

29 normospermic treated with 4000mg/die of myo-inositol and 400 µg of folic acid

Group Type SHAM_COMPARATOR

Myo-inositol normospermic

Intervention Type 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

13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid

Group Type ACTIVE_COMPARATOR

Myo-inositol OAT

Intervention Type 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

20 normospermic patients treated with 400 µg of folic acid

Group Type PLACEBO_COMPARATOR

Folic Acid normospermic

Intervention Type 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.

Interventions

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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.

Intervention Type 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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Undergoing to IVF cycle OAT

Exclusion Criteria

No undergoing to IVF cycle
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AGUNCO Obstetrics and Gynecology Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Palumbo, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Catania - Department of Surgery - Section of Obstetrics and Gynecology - Centre of Physiopathology of Reproduction

Gianfranco Carlomagno, Ph.D.

Role: STUDY_DIRECTOR

A.G.Un.Co. Obstetrics and gynaecology center

Locations

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Centre of Physiopathology of Reproduction

Catania, CT, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 35506389 (View on PubMed)

Other Identifiers

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INO-2103-GC

Identifier Type: -

Identifier Source: org_study_id

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