Effect of Treatment With Myo-inositol on Human Semen Parameters in Patients Undergoing In Vitro Fertilization Cycles

NCT ID: NCT01560065

Last Updated: 2012-03-22

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

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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Myo-Inositol (MI) is a precursors for the synthesis of phosphatidylinositol polyphosphates (PIPs). In male reproduction, it was shown that MI concentration in the seminiferous tubules is higher than in serum and it was increasing during the movement through the epididymis and the deferent duct. In the present study, the role of myo-inositol has been investigated as a possible antioxidant agent for the systemic treatment of male infertility and the improvement of the sperm's quality.

Samples of seminal fluid were obtained from two groups of patients undergoing to a IVF cycle: healthy subjects and subjects with oligoasthenospermia (OA, \< 15 mil/ml). The collected samples were submitted to optic microscopy in order to evaluate semen's volume, spermatozoa's number and motility, 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 for three months.

These values were compared with samples of seminal fluid of healthy patients undergoing to a IVF cycle for a female cause of infertility (control group).

Detailed Description

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Conditions

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Sperm Quality Oligoasthenospermia

Study Groups

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Normospermic patients

Group Type OTHER

myo-inositol + folic acid

Intervention Type DIETARY_SUPPLEMENT

4000mg myo-inositol + 400 µg folic acid

Oligoasthenospermic patients

Group Type OTHER

myo-inositol + folic acid

Intervention Type DIETARY_SUPPLEMENT

4000mg myo-inositol + 400 µg folic acid

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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myo-inositol + folic acid

4000mg myo-inositol + 400 µg folic acid

Intervention Type DIETARY_SUPPLEMENT

myo-inositol + folic acid

4000mg myo-inositol + 400 µg folic acid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 3-5 days of sexual abstinence

Exclusion Criteria

* systemic and endocrine diseases
* genital infections
* history of cryptorchidism or varicocele
* microorchidism
* hormonal treatment in the last six months
* alcohol intake, cigarette smoke and/or drug abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AGUNCO Obstetrics and Gynecology Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Catania, , Italy

Site Status

Countries

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Italy

References

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Colone M, Marelli G, Unfer V, Bozzuto G, Molinari A, Stringaro A. Inositol activity in oligoasthenoteratospermia--an in vitro study. Eur Rev Med Pharmacol Sci. 2010 Oct;14(10):891-6.

Reference Type BACKGROUND
PMID: 21222378 (View on PubMed)

Hinton BT, White RW, Setchell BP. Concentrations of myo-inositol in the luminal fluid of the mammalian testis and epididymis. J Reprod Fertil. 1980 Mar;58(2):395-9. doi: 10.1530/jrf.0.0580395.

Reference Type BACKGROUND
PMID: 7431272 (View on PubMed)

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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MI_IVF

Identifier Type: -

Identifier Source: org_study_id

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