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Clinical Trials/NCT04125017
NCT04125017CompletedNot Applicable

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

Aljazeera Hospital1 site in 1 country409 target enrollmentStarted: January 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
409
Locations
1
Primary Endpoint
The number of women who will have positive pregnancy test

Study Overview

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

Detailed Description

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 Unlike the slow freezing method, vitrification has better results in a complete elimination of ice crystal inside the cells as well as in the surrounding solution -Also, it has a significantly higher post-thawing survival rate in comparison to slow freezing method

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 44 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •women with infertility from 20 to 44 years

Exclusion Criteria

  • •women with age more than 44 or less than 20

Arms & Interventions

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

Intervention: ICSI with laser pulse (Device)

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

Intervention: ICSI with micro needle technique (Device)

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

Intervention: ICSI with laser pulse (Device)

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

Intervention: ICSI with micro needle technique (Device)

Outcomes

Primary Outcomes

The number of women who will have positive pregnancy test

Time Frame: 2 months

The number of women who will come pregnant after each technique

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Alalfy

Consultant of Obstetrics and Gynecology

Aljazeera Hospital

Study Sites (1)

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