Laser Assisted Sperm Selection of Viable Immotile Testicu... | NCT04675164

Studies
Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men

NCT04675164

Sponsor

Sohag University

Status

Completed

Last Update Posted

Nov 27, 2023Actual

Enrollment

168Actual

Phase

Not Applicable

Conditions

Azoospermia
IVF

Interventions

Laser Assisted Immotile Sperm Selection
Hypo-osmotic Swelling Test

Countries

Egypt

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

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Sep 30, 2023Actual

Completion Date

Sep 30, 2023Actual

First Submitted Date

Dec 15, 2020

First Submission Date that Met QC Criteria

Dec 15, 2020

First Posted Date

Dec 19, 2020Actual

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

Nov 22, 2023

Last Update Posted Date

Nov 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Alaa El-Dein Hasan, Assistant Lecturer of Dermatology, Venreology and Andrology, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study aims to investigate the outcome of ICSI after using LAISS for selection of viable immotile testicular sperm in azoospermic infertile men.

Patients will be randomly assigned to 2 groups. In (LAISS) group, viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group). In (HOST) group, viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).

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

168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LAISS group	Active Comparator	Viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group).	Device: Laser Assisted Immotile Sperm Selection
HOST group	Active Comparator	Viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).	Procedure: Hypo-osmotic Swelling Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser Assisted Immotile Sperm Selection	Device	LAISS will be performed using diode laser system at the lowest working power with a single laser shot at the lower one third of the sperm tail. If sperm tail curling occurred, the sperm is then viable and will be utilized for ICSI after immobilization in PVP.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rate	Presence of a fetal heartbeat at 6-7 weeks of pregnancy.	6- 7 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible couples are those undergoing ICSI due to azoospermia with testicular biopsy positive for sperm (either fresh or cryopreserved) following testicular sperm extraction (TESE) or aspiration (TESA).

Exclusion Criteria:

Cases with female factor infertility or woman age above 35 years will be excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ramadan SA Saleh, MD	Sohag Faculty of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajyal Hospital, IVF Center		Sohag		82524	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Share IPD upon justified request to study director

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Data shall become permanently available for share in Q3 2022.

Access Criteria

Justified request to study director

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053713	Azoospermia

Ancestor Terms

ID	Term
D007248	Infertility, Male
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

(LAISS) group: viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group).

(HOST) group: viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).

Masking Info

Masking

Triple

Masking Description

With an online tool, participants will be randomized to undergo ICSI with HOST and LAISS sperm selection arms with a 1:1 allocation ratio as per a computer-generated list, using permuted block sizes of 8, and 16, stratified for sites and fresh or cryopreserved sperm. Results of allocation will be in sealed opaque envelopes labeled with unique random codes. Clinicians, embryologists, and participants in all centers will have no access to allocation results. Upon consent, instructors will assign participants to the relevant group. Embryologists who will perform fertilization check and embryo grading will be unaware of the sperm selection method. Women will undergo only day 5 blastocysts transfer. This trial will also conceal the allocation from participants and clinical team.

Who Masked

ParticipantCare ProviderOutcomes Assessor