NCT04125017

Brief Summary

Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing

Trial Health

87
On Track

Trial Health Score

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

Enrollment
409

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

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

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 10, 2019

Last Update Submit

October 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of women who will have positive pregnancy test

    The number of women who will come pregnant after each technique

    2 months

Study Arms (2)

effect of using LASER pulse

OTHER

effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts as a previous step before vitrification in regarding their effect on embryo viability

Device: ICSI with laser pulseDevice: ICSI with micro needle technique

Micro-needle Technique

OTHER

effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts as a previous step before vitrification in regarding their effect on embryo viability

Device: ICSI with laser pulseDevice: ICSI with micro needle technique

Interventions

Using laser pulse before ICSI

Micro-needle Techniqueeffect of using LASER pulse

Using micro needle technique before ICSI

Micro-needle Techniqueeffect of using LASER pulse

Eligibility Criteria

Age20 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales who have infertility
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with infertility from 20 to 44 years

You may not qualify if:

  • women with age more than 44 or less than 20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adam

Giza, Egypt

Location

Related Publications (1)

  • Kamel Mohamed M, El-Noury MAH, Amer MK, Fakhry E, Alalfy M. Comparative study between two techniques for artificial shrinkage of blastocysts prior to vitrification: LASER pulse versus micro-needle technique in increasing chemical, clinical pregnancy and live birth rates after ICSI, a randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):4910-4917. doi: 10.1080/14767058.2021.1873265. Epub 2021 Feb 28.

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • manal kamel

    Adam hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Obstetrics and Gynecology

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

January 1, 2019

Primary Completion

January 4, 2020

Study Completion

February 5, 2020

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations