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

NCT04675164 | Completed DMC

• 1 other identifier: LAISS
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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).

Conditions

Azoospermia; IVF

Keywords

Laser Assisted Immotile Sperm Selection; Hypo-osmotic swelling test; ICSI; Testicular sperm

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Presence of a fetal heartbeat at 6-7 weeks of pregnancy.

  6- 7 weeks

Study Arms (2)

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

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.

LAISS group

Hypo-osmotic Swelling Test 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.

HOST group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Ajyal Hospital, IVF Center

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Azoospermia

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Ramadan SA Saleh, MD

  Sohag Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Dermatology, Venreology and Andrology

Model Details: (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).

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 19, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data shall become permanently available for share in Q3 2022.
• Access Criteria: Justified request to study director

Locations

EG (1)