Side of Embryo Biopsy Interfering Implantation Potential

January 12, 2019 updated by: Ahmad Mustafa Mohamed Metwalley

Effect of Embryo Biopsy Side on Post Biopsy Blastocyst Structurs and Implantation

Selection of side of embryo biopsy that will not interfering with implantation power of developed blastocyst embryo during biopsy procedure arranged for PGT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During process of embryo biopsy, it was indicated to avoid contacting cells closer to inner cell mass as it can decrease the quality of embryo and its structural composition. However, recommendation for collection from the trophectoderm (TE) side is indicated.

Absence of differentiation during cleavage-stage or morula stage at day 3 and day 4 respectively, will present the needful to focus a specific location for embryo biopsy during pre-blastocyst stages for embryo going to do genetic testing before implantation or embryo transfer.

In articulation around the second polar body or the animal pole of embryo, collection of the cell from the vegetal pole in crospondence to avoide collection form the animal pole is to be compare the results of implantation for biopsy done using the animal pole side or the random non organized biosy procedure.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahrain
      • Manama, Bahrain, 15006
        • AHMAD Barakat
  • Egypt
      • Sohag, Egypt, 15006
        • Ibn Sina IVF Center- Ibn Sina Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • grade 1 or 2 embryos at eight cell stage or 8-1/ 8-2 embryo quality.

Exclusion Criteria:

  • grade 3 embryo at day 3, or 8-3 embryos.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vegetal Pole blastomer embryo
for day 3 embryo biopsy / cleavage stage: Blastomere collection from opposite side to the 2nd polar body or from vegetal pole.
Procedure: Vegetal Pole blastomer embryo
for day 3 embryo biopsy / cleavage stage
Other Names:
  • Biopsy embryo from sides considered far from ICM location.
Procedure: Animal Pole blastomer embryo
for day 3 embryo biopsy / cleavage stage
Other Names:
  • Random biopsy without considering specific location
Experimental: Animal Pole blastomer embryo
for day 3 embryo biopsy / cleavage stage: Blastomere collection from and side around the 2nd polar body and not the vegetal pole.
Procedure: Vegetal Pole blastomer embryo
for day 3 embryo biopsy / cleavage stage
Other Names:
  • Biopsy embryo from sides considered far from ICM location.
Procedure: Animal Pole blastomer embryo
for day 3 embryo biopsy / cleavage stage
Other Names:
  • Random biopsy without considering specific location

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blastocyst location of ICM at day 5
Time Frame: 2 months
describing the location of the inner cell mass (ICM) in location to the zona peluceda (ZP) drilling opening.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation power
Time Frame: 2 months
calculating the pregnancy rate for cases after biopsy.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmad Mustafa Mohamed Metwalley

Collaborators

Ibn Sina Hospital

Investigators

  • Principal Investigator: Ahmad M Metwalley, Al Baraka Fertility Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 2, 2018

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 12, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Embryo Biopsy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After abstract submission or after final approval for scientific paper

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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