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Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome (MI_ICSI)

Primary Purpose

Couple Sterility

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Myo-inositol
untreated
Sponsored by
AGUNCO Obstetrics and Gynecology Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Couple Sterility focused on measuring Myoinositol, ART, EMBRYO QUALITY

Eligibility Criteria

30 Years - 42 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • couple counselled for IVF

Exclusion Criteria:

  • cryopreserved sample

Sites / Locations

  • TECNOLAB

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

untreated

myo-inositol

Arm Description

Semen was prepared with routinely used media

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

Outcomes

Primary Outcome Measures

Fetilization rate

Secondary Outcome Measures

Embryo quality

Full Information

First Posted
January 27, 2014
Last Updated
July 30, 2021
Sponsor
AGUNCO Obstetrics and Gynecology Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02050672
Brief Title
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome
Acronym
MI_ICSI
Official Title
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome: a Prospective, Randomized Sibling-oocyte Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
July 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGUNCO Obstetrics and Gynecology Centre

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Couple Sterility
Keywords
Myoinositol, ART, EMBRYO QUALITY

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
untreated
Arm Type
Active Comparator
Arm Description
Semen was prepared with routinely used media
Arm Title
myo-inositol
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol
Intervention Type
Other
Intervention Name(s)
untreated
Primary Outcome Measure Information:
Title
Fetilization rate
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Embryo quality
Time Frame
Day 2 to Day 5

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: couple counselled for IVF Exclusion Criteria: cryopreserved sample
Facility Information:
Facility Name
TECNOLAB
City
Milan
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22656408
Citation
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.
Results Reference
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PubMed Identifier
22086556
Citation
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.
Results Reference
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PubMed Identifier
21434479
Citation
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.
Results Reference
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Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome

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