Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome

NCT ID: NCT02050672

Last Updated: 2021-08-06

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

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2021-07-31

Brief Summary

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In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes.

In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen.

Detailed Description

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Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the cell signaling pathways and it is involved in the regulation of intracellular calcium.

Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte and spematozoa are nursed in a medium congaing hig MI concentration.

Furthermore, it has been demonstrated that, in oligoasthenoteratozoospermic patients, in vitro incubation with 2 mg/ml of myo increase significantly the number of spermatozoa with high mitochondrial membrane potential (MMP). Moreover, it has been found that the in vitro fertilization rate is correlated with the percentage of high MMP spermatozoa.

Conditions

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Couple Sterility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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untreated

Semen was prepared with routinely used media

Group Type ACTIVE_COMPARATOR

untreated

Intervention Type OTHER

myo-inositol

routinely used semen preparation media have been enriched with myo-inositol 2mg/ml.

in particular the stock solution was prepared in order to add 15microliters per ml of medium

Group Type EXPERIMENTAL

Myo-inositol

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Myo-inositol

Intervention Type DIETARY_SUPPLEMENT

untreated

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* couple counselled for IVF

Exclusion Criteria

* cryopreserved sample
Minimum Eligible Age

30 Years

Maximum Eligible Age

42 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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TECNOLAB

Milan, , Italy

Site Status

Countries

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Italy

References

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Condorelli RA, La Vignera S, Bellanca S, Vicari E, Calogero AE. Myoinositol: does it improve sperm mitochondrial function and sperm motility? Urology. 2012 Jun;79(6):1290-5. doi: 10.1016/j.urology.2012.03.005.

Reference Type BACKGROUND
PMID: 22656408 (View on PubMed)

Nomikos M, Swann K, Lai FA. Starting a new life: sperm PLC-zeta mobilizes the Ca2+ signal that induces egg activation and embryo development: an essential phospholipase C with implications for male infertility. Bioessays. 2012 Feb;34(2):126-34. doi: 10.1002/bies.201100127. Epub 2011 Nov 16.

Reference Type BACKGROUND
PMID: 22086556 (View on PubMed)

Condorelli RA, La Vignera S, Di Bari F, Unfer V, Calogero AE. Effects of myoinositol on sperm mitochondrial function in-vitro. Eur Rev Med Pharmacol Sci. 2011 Feb;15(2):129-34.

Reference Type BACKGROUND
PMID: 21434479 (View on PubMed)

Other Identifiers

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MI_ICSI

Identifier Type: -

Identifier Source: org_study_id

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