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

NCT ID: NCT04675164

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-09-30

Brief Summary

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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

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Conditions

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Azoospermia IVF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

(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).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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LAISS group

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

Group Type ACTIVE_COMPARATOR

Laser Assisted Immotile Sperm Selection

Intervention Type 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.

HOST group

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

Group Type ACTIVE_COMPARATOR

Hypo-osmotic Swelling Test

Intervention Type PROCEDURE

HOST will be performed by transferring immotile sperms from incubation droplet into HOST droplet, with any sperm showing tail swelling will be identified as viable and will be utilized for ICSI after immediate transfer and immobilization.

Interventions

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Laser Assisted Immotile Sperm Selection

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.

Intervention Type DEVICE

Hypo-osmotic Swelling Test

HOST will be performed by transferring immotile sperms from incubation droplet into HOST droplet, with any sperm showing tail swelling will be identified as viable and will be utilized for ICSI after immediate transfer and immobilization.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Alaa El-Dein Hasan

Assistant Lecturer of Dermatology, Venreology and Andrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramadan SA Saleh, MD

Role: STUDY_DIRECTOR

Sohag Faculty of Medicine

Locations

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Ajyal Hospital, IVF Center

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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LAISS

Identifier Type: -

Identifier Source: org_study_id