G-IVF and Sperm Parameters

August 29, 2023 updated by: Vitrolife

Does Adding Medium to Fresh Semen Samples Increase Motility After Preparation?

The aim of this study is to investigate if adding a fixed volume of a physiological solution to a freshly produced sperm sample will affect sperm characteristics.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Maroussi, Greece, 151 23
        • IASO Maternity and Gynecology Clinic
        • Contact:
        • Contact:
          • Eftychia Sklavolia
        • Principal Investigator:
          • Alexandra Spyrou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients producing a pre-clinical semen sample at the clinic

Exclusion Criteria:

  • Patients with known azoospermia
  • Patients who have had a vasectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: G-IVF PLUS
Device: G-IVF PLUS
Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of progressive motile sperm (%)
Time Frame: 10 minutes of assessment will be used to count the motile sperm for each sample.
Proportion of progressive motile sperm after sample preparation
10 minutes of assessment will be used to count the motile sperm for each sample.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm yield (%)
Time Frame: 10 minutes used to assess motilty (as for primary outcome)
Percentage of total number of motile sperm after sperm preperation
10 minutes used to assess motilty (as for primary outcome)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitrolife

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

October 24, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-GR-GIVFSP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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