AzoospermiaNCT04675164
Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men
A study testing Laser Assisted Immotile Sperm Selection and Hypo-osmotic Swelling Test in people with Azoospermia and IVF, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Azoospermia, IVF
- What is being tested?
- Laser Assisted Immotile Sperm Selection and Hypo-osmotic Swelling Test
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Cases with female factor infertility or woman age above 35 years will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of ICSI Using Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men: a Randomized Controlled Trial
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
- Being tested
- Laser Assisted Immotile Sperm Selection, Hypo-osmotic Swelling Test
- Keywords
- Laser Assisted Immotile Sperm Selection, Hypo-osmotic swelling test, ICSI, Testicular sperm
- Medical subject headings
- Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Assisted Immotile Sperm SelectionDevice
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.
Hypo-osmotic Swelling TestProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| LAISS group | Active comparator | Viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group). Receives: 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). Receives: Procedure: Hypo-osmotic Swelling Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Presence of a fetal heartbeat at 6-7 weeks of pregnancy.
Measured: 6- 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Oct 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AzoospermiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Alaa El-Dein Hasan, Sohag University
- Investigators
- Ramadan SA Saleh, MD, Study director, Sohag Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675164
- Sponsor's protocol ID
- LAISS
- Status last verified
- Nov 2023
- First submitted
- 15 Dec 2020
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share IPD upon justified request to study director
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of ICSI Using Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04675164
- Acronym / sponsor ID
- LAISS
- Conditions
- Azoospermia, IVF
- Keywords
- Laser Assisted Immotile Sperm Selection, Hypo-osmotic swelling test, ICSI, Testicular sperm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| LAISS group | Active comparator | Device: Laser Assisted Immotile Sperm SelectionViable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group). |
| HOST group | Active comparator | Procedure: Hypo-osmotic Swelling TestViable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Cases with female factor infertility or woman age above 35 years will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Assisted Immotile Sperm SelectionLAISS 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. | Device | LAISS group |
| Hypo-osmotic Swelling TestHOST 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. | Procedure or surgery | HOST group |
Primary outcome
Clinical pregnancy rate
Time frame: 6- 7 weeks
Presence of a fetal heartbeat at 6-7 weeks of pregnancy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: Yes. Share IPD upon justified request to study director
Related trials for Azoospermia
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Active, not recruitingPhase 1/2
A Novel Aromatase Inhibitor, Leflutrozole, for Treatment of Non-Obstructive Azoospermia
Infertility Due to Azoospermia, Infertility, Male
RecruitingObservational study
Maternal Inheritance of a Pathogenic MT-ND1 Mutation Causes Mitochondrial Dysfunction and Spermatogenic Failure in Men
Azoospermia, Nonobstructive, Cryptozoospermia
RecruitingPhase 1/2
Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility.
Non-obstructive Azoospermia
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramadan SA Saleh, MD study director
Sohag Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Assisted Immotile Sperm Selection and Hypo-osmotic Swelling Test in people with Azoospermia and IVF, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 6- 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.