Laser Assisted ICSI; Has it Role Whatsoever? Does it Affect the ICSI Outcome Positively?1
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Clinical pregnancy rate
Study Overview
Brief 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?!. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 20 Years to 37 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged from 20 years old to 37 years old
- •good res-ponders
- •gives more than 15 oocytes
- •endometrial thickness more than 9 mm
Exclusion Criteria
- •poor res-ponders
- •severe oligoasthinozoospermia of male partners
- •testicular samples
- •Poor quality oocytes
Outcomes
Primary Outcomes
Clinical pregnancy rate
Time Frame: three-four weeks after embryo transfer
confirmed by sac observation using ultrasound
Secondary Outcomes
- Blastulation rate(5 days later after ICSI procedure)
- Hatching rate(5 days later after ICSI procedure)