NCT02050672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

7.7 years

First QC Date

January 27, 2014

Last Update Submit

July 30, 2021

Conditions

Couple Sterility

Keywords

MyoinositolARTEMBRYO QUALITY

Outcome Measures

Primary Outcomes (1)

  • Fetilization rate

    Day 1

Secondary Outcomes (1)

  • Embryo quality

    Day 2 to Day 5

Study Arms (2)

untreated

ACTIVE COMPARATOR

Semen was prepared with routinely used media

Other: untreated

myo-inositol

EXPERIMENTAL

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

Dietary Supplement: Myo-inositol

Interventions

Myo-inositolDIETARY_SUPPLEMENT
myo-inositol
untreatedOTHER
untreated

Eligibility Criteria

Age30 Years - 42 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • couple counselled for IVF

You may not qualify if:

  • cryopreserved sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TECNOLAB

Milan, Italy

Location

Related Publications (3)

  • 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.

    PMID: 22656408BACKGROUND

  • 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.

    PMID: 22086556BACKGROUND

  • 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.

    PMID: 21434479BACKGROUND

MeSH Terms

Interventions

Inositol

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 31, 2014

Study Start

May 1, 2013

Primary Completion

January 1, 2021

Study Completion

July 1, 2021

Last Updated

August 6, 2021

Record last verified: 2021-07

Locations

IT(1)