NCT05597631

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

October 24, 2022

Last Update Submit

August 29, 2023

Conditions

Infertility, Male

Keywords

Sperm motilitySperm preparationOsmolarity

Outcome Measures

Primary Outcomes (1)

  • Proportion of progressive motile sperm (%)

    Proportion of progressive motile sperm after sample preparation

    10 minutes of assessment will be used to count the motile sperm for each sample.

Secondary Outcomes (1)

  • Sperm yield (%)

    10 minutes used to assess motilty (as for primary outcome)

Study Arms (2)

Control

NO INTERVENTION

Control

G-IVF PLUS

EXPERIMENTAL

G-IVF PLUS

Device: G-IVF PLUS

Interventions

G-IVF PLUSDEVICE

Experimental

G-IVF PLUS

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IASO Maternity and Gynecology Clinic

Marousi, 151 23, Greece

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Central Study Contacts

Susanna Apter, PhL

CONTACT

+46701648828sapter@vitrolife.com

Alexandra Spyrou

CONTACT

+302106184030alex.spy.17@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 28, 2022

Study Start

October 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

GR(1)