Back to resultsG-IVF and Sperm Parameters
Primary Purpose
Infertility, Male
Status
Not yet recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
G-IVF PLUS
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Male focused on measuring Sperm motility, Sperm preparation, Osmolarity
Eligibility Criteria
Inclusion Criteria:
- Patients producing a pre-clinical semen sample at the clinic
Exclusion Criteria:
- Patients with known azoospermia
- Patients who have had a vasectomy
Sites / Locations
- IASO Maternity and Gynecology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
G-IVF PLUS
Arm Description
Control
G-IVF PLUS
Outcomes
Primary Outcome Measures
Proportion of progressive motile sperm (%)
Proportion of progressive motile sperm after sample preparation
Secondary Outcome Measures
Sperm yield (%)
Percentage of total number of motile sperm after sperm preperation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05597631
Brief Title
G-IVF and Sperm Parameters
Official Title
Does Adding Medium to Fresh Semen Samples Increase Motility After Preparation?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitrolife
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
Sperm motility, Sperm preparation, Osmolarity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control
Arm Title
G-IVF PLUS
Arm Type
Experimental
Arm Description
G-IVF PLUS
Intervention Type
Device
Intervention Name(s)
G-IVF PLUS
Intervention Description
Experimental
Primary Outcome Measure Information:
Title
Proportion of progressive motile sperm (%)
Description
Proportion of progressive motile sperm after sample preparation
Time Frame
10 minutes of assessment will be used to count the motile sperm for each sample.
Secondary Outcome Measure Information:
Title
Sperm yield (%)
Description
Percentage of total number of motile sperm after sperm preperation
Time Frame
10 minutes used to assess motilty (as for primary outcome)
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients producing a pre-clinical semen sample at the clinic
Exclusion Criteria:
Patients with known azoospermia
Patients who have had a vasectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanna Apter, PhL
Phone
+46701648828
Email
sapter@vitrolife.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Spyrou
Phone
+302106184030
Email
alex.spy.17@gmail.com
Facility Information:
Facility Name
IASO Maternity and Gynecology Clinic
City
Maroussi
ZIP/Postal Code
151 23
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Spyrou
Phone
+302106184030
Email
alex.spy.17@gmail.com
First Name & Middle Initial & Last Name & Degree
Eftychia Sklavolia
First Name & Middle Initial & Last Name & Degree
Alexandra Spyrou
12. IPD Sharing Statement
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G-IVF and Sperm Parameters
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