Side of Embryo Biopsy Interfering Implantation Potential

Not Applicable

Completed

• Conditions: Preimplantation Diagnosis
• Interventions: Procedure: Vegetal Pole blastomer embryo; Procedure: Animal Pole blastomer embryo

• Registration Number: NCT02902614
• Lead Sponsor: Ahmad Mustafa Mohamed Metwalley

Brief Summary

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

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-12
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vegetal Pole blastomer embryo	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.
Animal Pole blastomer embryo	Vegetal 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.
Animal Pole blastomer embryo	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.
Vegetal Pole blastomer embryo	Animal Pole blastomer embryo	for day 3 embryo biopsy / cleavage stage: Blastomere collection from opposite side to the 2nd polar body or from vegetal pole.

Primary Outcome Measures

Name	Time	Method
blastocyst location of ICM at day 5	2 months	describing the location of the inner cell mass (ICM) in location to the zona peluceda (ZP) drilling opening.

Secondary Outcome Measures

Name	Time	Method
Implantation power	2 months	calculating the pregnancy rate for cases after biopsy.

Trial Locations

Locations (2)

Ibn Sina IVF Center- Ibn Sina Hospital; 🇪🇬 Sohag, Egypt

AHMAD Barakat; 🇧🇭 Manama, Bahrain