Back to resultsLaser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men
Primary Purpose
Azoospermia, IVF
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser Assisted Immotile Sperm Selection
Hypo-osmotic Swelling Test
Sponsored by
About this trial
This is an interventional treatment trial for Azoospermia focused on measuring Laser Assisted Immotile Sperm Selection, Hypo-osmotic swelling test, ICSI, Testicular sperm
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.
Sites / Locations
- Ajyal Hospital, IVF CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LAISS group
HOST group
Arm Description
Viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group).
Viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Presence of a fetal heartbeat at 6-7 weeks of pregnancy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04675164
Brief Title
Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men
Official Title
Outcome of ICSI Using Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Azoospermia, IVF
Keywords
Laser Assisted Immotile Sperm Selection, Hypo-osmotic swelling test, ICSI, Testicular sperm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LAISS group
Arm Type
Active Comparator
Arm Description
Viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group).
Arm Title
HOST group
Arm Type
Active Comparator
Arm Description
Viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).
Intervention Type
Device
Intervention Name(s)
Laser Assisted Immotile Sperm Selection
Intervention Description
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
Procedure
Intervention Name(s)
Hypo-osmotic Swelling Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Presence of a fetal heartbeat at 6-7 weeks of pregnancy.
Time Frame
6- 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamad AH Mohamad, MSc
Phone
+201000146001
Email
Mohammed.Suity@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ramadan SA Saleh, MD
Phone
01005423054
Email
salehr2010@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramadan SA Saleh, MD
Organizational Affiliation
Sohag Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ajyal Hospital, IVF Center
City
Sohag
ZIP/Postal Code
82524
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramadan SA Saleh, MD
Phone
01005423054
Email
salehr2010@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Share IPD upon justified request to study director
IPD Sharing Time Frame
Data shall become permanently available for share in Q3 2022.
IPD Sharing Access Criteria
Justified request to study director
Learn more about this trial
Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men
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