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Atrificial Shrinkage of Blastocyst Before In Vitro Fertilization

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ICSI with laser pulse
ICSI with micro needle technique
Sponsored by
Aljazeera Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility

Eligibility Criteria

20 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women with infertility from 20 to 44 years

Exclusion Criteria:

  • women with age more than 44 or less than 20

Sites / Locations

  • Adam

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

effect of using LASER pulse

Micro-needle Technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

The number of women who will have positive pregnancy test
The number of women who will come pregnant after each technique

Secondary Outcome Measures

Full Information

First Posted
October 10, 2019
Last Updated
October 6, 2023
Sponsor
Aljazeera Hospital
Collaborators
Adam International Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04125017
Brief Title
Atrificial Shrinkage of Blastocyst Before In Vitro Fertilization
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 4, 2020 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aljazeera Hospital
Collaborators
Adam International Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts .
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
effect of using LASER pulse
Arm Type
Other
Arm Description
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
Arm Title
Micro-needle Technique
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
ICSI with laser pulse
Intervention Description
Using laser pulse before ICSI
Intervention Type
Device
Intervention Name(s)
ICSI with micro needle technique
Intervention Description
Using micro needle technique before ICSI
Primary Outcome Measure Information:
Title
The number of women who will have positive pregnancy test
Description
The number of women who will come pregnant after each technique
Time Frame
2 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females who have infertility
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women with infertility from 20 to 44 years Exclusion Criteria: women with age more than 44 or less than 20
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
manal kamel
Organizational Affiliation
Adam hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adam
City
Giza
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33645399
Citation
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.
Results Reference
derived

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Atrificial Shrinkage of Blastocyst Before In Vitro Fertilization

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