Laser Assistance to Improve ICSI OutcomeNCT04455412
Laser Assisted ICSI; Has it Role Whatsoever?
A study testing Laser Assisted ICSI in people with Laser Assistance to Improve ICSI Outcome, run by Royal Fertility Center, Egypt at 1 site in Egypt.
Trial summary
laser-assisted ICSI (LA-ICSI) was described to be a new method combining a less invasive ICSI technique with assisted hatching.This procedure is usually used for MII oocytes possessing oolemma breakage difficulties, but why not using it for even normal Oocytes?!. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laser Assistance to Improve ICSI Outcome
- What is being tested?
- Laser Assisted ICSI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to Jan 2024
- 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 20 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged from 20 years old to 37 years old
- good res-ponders
- gives more than 15 oocytes
- endometrial thickness more than 9 mm
Who cannot join
- poor res-ponders
- severe oligoasthinozoospermia of male partners
- testicular samples
- Poor quality oocytes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Assisted ICSI; Has it Role Whatsoever? Does it Affect the ICSI Outcome Positively?1
laser-assisted ICSI (LA-ICSI) was described to be a new method combining a less invasive ICSI technique with assisted hatching.This procedure is usually used for MII oocytes possessing oolemma breakage difficulties, but why not using it for even normal Oocytes?!. Especially because data indicated that in addition to an improved oocyte survival, this new approach increases the hatching rate in vitro. But since it is still debatable that such a small opening might impair the hatching process, so modified zona thinning technique was proposed for more embryo safety.
Read the detailed description
This study aims to compare the LA- ICSI by drilling a micro hole (LAD-ICSI) and modified LA-ICSI by zona pellucida thinning (LAT-ICSI) with conventional ICSI in order to effectively assess whether this approach can be applied routinely to improve ICSI outcome.
One arm study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes.
The rates of maturation, fertilization, Devision, Blastulation and good quality blastulation rates were assessed in the three groups
Cases were randomly selected for embryo transfer from the three groups,Then chemical pregnancy and clinical pregnancy rates were compared between the three groups.
- Conditions
- Laser Assistance to Improve ICSI Outcome
- Being tested
- Laser Assisted ICSI
- Keywords
- Laser assisted-ICSI, Zona pellucida thinning, ICSI, embryo good quality rate, hatching rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Assisted ICSIProcedure or surgery
using OCTICS laser device to do small opening or zona thinning to improve ICSI outcome
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Conventional ICSI procedure was done for first portion of sibling oocytes |
| Study group 1 | Experimental | Laser assisted drilling ICSI procedure was done for second portion of sibling oocytes Receives: Procedure: Laser Assisted ICSI |
| Study group 2 | Experimental | Laser assisted thinning ICSI procedure was done for Third portion of sibling oocytes Receives: Procedure: Laser Assisted ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
confirmed by sac observation using ultrasound
Measured: three-four weeks after embryo transfer
Secondary outcomes (2)
Blastulation rate
number of blastocysts that are grown from devided embryos
Measured: 5 days later after ICSI procedure
Hatching rate
number of blastocysts that hatch out of zona
Measured: 5 days later after ICSI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Feb 2020
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: recruitment is stopped waiting for funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser Assistance to Improve ICSI OutcomeStudies of the same condition, open and under way.
- 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
- study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes. then Cases randomly selected for embryo transfer from each group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Fertility Center, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455412
- Sponsor's protocol ID
- RoyalFertility 001
- Status last verified
- Sep 2022
- First submitted
- 28 Jun 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Assisted ICSI; Has it Role Whatsoever? Does it Affect the ICSI Outcome Positively?1
- ClinicalTrials.gov ID
- NCT04455412
- Acronym / sponsor ID
- RoyalFertility 001
- Conditions
- Laser Assistance to Improve ICSI Outcome
- Keywords
- Laser assisted-ICSI, Zona pellucida thinning, ICSI, embryo good quality rate, hatching rate
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: recruitment is stopped waiting for funds
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Royal Fertility Center, EgyptUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 2 Jul 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.
laser-assisted ICSI (LA-ICSI) was described to be a new method combining a less invasive ICSI technique with assisted hatching.This procedure is usually used for MII oocytes possessing oolemma breakage difficulties, but why not using it for even normal Oocytes?!. Especially because data indicated that in addition to an improved oocyte survival, this new approach increases the hatching rate in vitro. But since it is still debatable that such a small opening might impair the hatching process, so modified zona thinning technique was proposed for more embryo safety.
Detailed description
This study aims to compare the LA- ICSI by drilling a micro hole (LAD-ICSI) and modified LA-ICSI by zona pellucida thinning (LAT-ICSI) with conventional ICSI in order to effectively assess whether this approach can be applied routinely to improve ICSI outcome.
One arm study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes.
The rates of maturation, fertilization, Devision, Blastulation and good quality blastulation rates were assessed in the three groups
Cases were randomly selected for embryo transfer from the three groups,Then chemical pregnancy and clinical pregnancy rates were compared between the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- study divided into three interventions; Conventional ICSI (control group) was compared with LAD-ICSI (Study group 1) and LAT- ICSI (study group 2) in sibling oocytes. then Cases randomly selected for embryo transfer from each group
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Conventional ICSI procedure was done for first portion of sibling oocytes |
| Study group 1 | Experimental | Procedure: Laser Assisted ICSILaser assisted drilling ICSI procedure was done for second portion of sibling oocytes |
| Study group 2 | Experimental | Procedure: Laser Assisted ICSILaser assisted thinning ICSI procedure was done for Third portion of sibling oocytes |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged from 20 years old to 37 years old
- good res-ponders
- gives more than 15 oocytes
- endometrial thickness more than 9 mm
Key exclusion criteria (4 listed)
- poor res-ponders
- severe oligoasthinozoospermia of male partners
- testicular samples
- Poor quality oocytes
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 ICSIusing OCTICS laser device to do small opening or zona thinning to improve ICSI outcome | Procedure or surgery | Study group 1, Study group 2 |
Primary outcome
Clinical pregnancy rate
Time frame: three-four weeks after embryo transfer
confirmed by sac observation using ultrasound
2 secondary outcomes
Blastulation rate
Time frame: 5 days later after ICSI procedure
Hatching rate
Time frame: 5 days later after ICSI procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ICSI in people with Laser Assistance to Improve ICSI Outcome, run by Royal Fertility Center, Egypt 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 4 inclusion and 4 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: paused, as of the sponsor's last update on 21 Sep 2022. 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?
Results are not available in the source record.
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: three-four weeks after embryo transfer). 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 21 Sep 2022.