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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04455412
Other study ID # RoyalFertility 001
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date January 2024

Study information

Verified date September 2022
Source Royal Fertility Center, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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?!. 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 120
Est. completion date January 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 37 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Laser Assistance to Improve ICSI Outcome

Intervention

Procedure:
Laser Assisted ICSI
using OCTICS laser device to do small opening or zona thinning to improve ICSI outcome

Locations

Country Name City State
Egypt Royal Fertility Center Mansoura Daqahlia

Sponsors (1)

Lead Sponsor Collaborator
Royal Fertility Center, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate confirmed by sac observation using ultrasound three-four weeks after embryo transfer
Secondary Blastulation rate number of blastocysts that are grown from devided embryos 5 days later after ICSI procedure
Secondary Hatching rate number of blastocysts that hatch out of zona 5 days later after ICSI procedure