G-IVF and Sperm Parameters | NCT05597631

Studies
G-IVF and Sperm Parameters

NCT05597631

Sponsor

Vitrolife

Status

Unknown status

Last Update Posted

Aug 30, 2023Actual

Enrollment

118Estimated

Phase

Not Applicable

Conditions

Infertility, Male

Interventions

G-IVF PLUS

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2023Estimated

Primary Completion Date

Mar 2024Estimated

Completion Date

Apr 2024Estimated

First Submitted Date

Oct 24, 2022

First Submission Date that Met QC Criteria

Oct 24, 2022

First Posted Date

Oct 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2023

Last Update Posted Date

Aug 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Control
G-IVF PLUS	Experimental	G-IVF PLUS	Device: G-IVF PLUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G-IVF PLUS	Device	Experimental	G-IVF PLUS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Susanna Apter, PhL	Contact	+46701648828		sapter@vitrolife.com
Alexandra Spyrou	Contact	+302106184030		alex.spy.17@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IASO Maternity and Gynecology Clinic		Marousi		151 23	Greece

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility

Browse Leaves

Not provided

Browse Branches

Not provided