NCT05311553

Brief Summary

Two hundred cycles will be enrolled (100 laser-assisted thinning and 100 laser-assisted drillings). They will be compared regarding the implantation and clinical pregnancy rates

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

March 27, 2022

Last Update Submit

October 19, 2022

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Implantation rate

    Implantation rate = the total number of early gestational sacs/the total number of transferred embryos × 100%.

    at 6 weeks of pregnancy

Secondary Outcomes (1)

  • Clinical pregnancy rate

    at 6 weeks of pregnancy

Study Arms (2)

Zona pellucida thinning

EXPERIMENTAL

thinning will be performed without reaching the inner membrane of the Zona pellucida thickness.

Procedure: Zona pellucida thinning

Zona pellucida drilling

EXPERIMENTAL

an opening will be made from the outside to the inside of the Zona pellucida.

Procedure: Zona pellucida drilling

Interventions

Zona pellucida thinningPROCEDURE

Laser-assisted hatching will be conducted using a Laser System with a 1.48-μm diode laser at 300 m W through thinning. The laser thinning will be performed by making 2-3 holes without reaching the inner membrane at a depth of60-80% of the Zona pellucida thickness.

Zona pellucida thinning
Zona pellucida drillingPROCEDURE

Laser-assisted hatching will be conducted using a Laser System with a 1.48-μm diode laser at 300 m W through drilling. The laser opening will be made from the outside to the inside of the Zona pellucida.

Zona pellucida drilling

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who have a previous ICSI failure, unexplained infertility or male infertility

You may not qualify if:

  • Patients with hydrosalpinx, pyosalpinx, endometriosis, or uterine fibroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private IVF Center

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ahmed Ayoub

    National Research Centre, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mazen Abdel-Rasheed

CONTACT

+201111242366doctor_mazen@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2022

First Posted

April 5, 2022

Study Start

October 1, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

October 21, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)