Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Azoospermia
  • IVF
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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: Triple (Participant, Care Provider, Outcomes Assessor)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.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 35 years
Gender
Both males and females

Description

Not Provided

Not Provided

Tracking Information

NCT #
NCT04675164
Collaborators
Not Provided
Investigators
Study Director: Ramadan SA Saleh, MD Sohag Faculty of Medicine