NCT03665103

Brief Summary

Degeneration rate after ICSI is expectable but decreasing it is a goal. Laser-assisted ICSI can serve to decrease this degeneration rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
966

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 6, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

September 6, 2018

Last Update Submit

August 5, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • oocyte survival after injection

    6 days of culture

Secondary Outcomes (4)

  • blastocyst formation rate

    6 days of culture

  • embryo utilization rate

    6 days of culture

  • clinical pregnancy rate

    four weeks after embryo transfer

  • ongoing pregnancy rate

    Twelve weeks of gestation

Study Arms (2)

Laser-assisted ICSI

EXPERIMENTAL
Other: Laser-assisted ICSI

conventional ICSI

NO INTERVENTION

Interventions

Laser-assisted ICSIOTHER

Laser opening of the zona pellucida.

Laser-assisted ICSI

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • all ICSI cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IbnSina IVF Center

Sohag, Egypt

Location

Related Publications (1)

  • Fawzy M, Emad M, Mahran A, Abdelrahman MY, Fetih AN, Abdelghafar H, Elsuity MA, Rashed H, Sabry M. A randomized controlled trial of laser-assisted ICSI. Hum Reprod. 2020 Dec 1;35(12):2692-2700. doi: 10.1093/humrep/deaa160.

    PMID: 32995832DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IVF Lab Director

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 11, 2018

Study Start

September 17, 2018

Primary Completion

August 1, 2019

Study Completion

August 5, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)