G-IVF and Sperm Parameters

• Sponsor: Vitrolife (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05597631
• Collaborator: (none)
• Enrollment: 118
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 16.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male	Device: G-IVF PLUS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does Adding Medium to Fresh Semen Samples Increase Motility After Preparation?
• Anticipated Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of progressive motile sperm (%) [10 minutes of assessment will be used to count the motile sperm for each sample.]

   Proportion of progressive motile sperm after sample preparation

Secondary Outcome Measures

1. Sperm yield (%) [10 minutes used to assess motilty (as for primary outcome)]

   Percentage of total number of motile sperm after sperm preperation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with known azoospermia

• Patients who have had a vasectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IASO Maternity and Gynecology Clinic	Maroussi		Greece	151 23

Sponsors and Collaborators

• Vitrolife

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vitrolife
• ClinicalTrials.gov Identifier: NCT05597631
• Other Study ID Numbers: 2022-GR-GIVFSP
• First Posted: Oct 28, 2022
• Last Update Posted: Nov 14, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vitrolife: Sperm motility; Sperm preparation; Osmolarity
• Additional relevant MeSH terms: Infertility; Infertility, Male

Study Results

No Results Posted as of Nov 14, 2022