The Importance of Blastocyst Diamater and Its Correlation to Reproductive Outcomes in PGT-A Cases

NCT ID: NCT05499988

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-07

Study Completion Date

2023-12-31

Brief Summary

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Morphometric measurement of blastocyst diameter was taken on the day of trophoectoderm biopsy. PGT-A was done using NGS platform, followed by thawing and transfer of euploid blastocyts. Follow up of the Pregnancy and implantation rates is done and recorded to study the correlation between the diameter and reproductive outcomes of the blastocyst.

Detailed Description

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Blastocyst morphological grading proposed by Gardner and Schoolcraft including the expansion degree, inner cell mass, and trophoectoderm assessment has proved its importance. Blastocyst expansion degree that can presented in diameter is linked to the blastocyst implantation and overall success.

In order to evaluate the importance of blastocyst diameter in PGT-A cases, measurements will be taken on the day of trophoectoderm biopsy TE (diameter in μm), followed by TE biopsy using flicking technique. Next, PGT-A will be done using NGS platform and results will be confirmed using PGT-ai. Thawing of euploid blastocyst will take place and expansion degree, survival rate will be recorded. Patient will be followed up for the clinical pregnancy and implantation rates.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Female aged 18-45 years old
* Male aged 18-60 years old
* ICSI cases having PGT-A for their blastocysts
* Must have their blastocysts cultured in time lapse incubator

Exclusion Criteria

* Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
* Use of donor oocytes or sperm
* Use of gestational carrier
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ganin Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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Eman Hasanen

Embryologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Hasanen, BSc.

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Manar Hozayen, MSc.

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Amr Elshimy, BSc.

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Hanaa Alkhader

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Hosam Zaki, MSc, FRCOG

Role: STUDY_DIRECTOR

Ganin Fertility Center

Samar Gamal, BP

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Locations

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Ganin Fertility Center

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eman Hasanen, BSc.

Role: CONTACT

01282012291

Manar Hozayen, MSc.

Role: CONTACT

01229483320

Facility Contacts

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Hosam Zaki

Role: primary

Other Identifiers

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GFC-006

Identifier Type: -

Identifier Source: org_study_id

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