The Importance of Blastocyst Diamater and Its Correlation to Reproductive Outcomes in PGT-A Cases
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
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participants targeted
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Started Aug 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2022
CompletedFirst Submitted
Initial submission to the registry
August 11, 2022
CompletedFirst Posted
Study publicly available on registry
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedSeptember 22, 2022
September 1, 2022
1.4 years
August 11, 2022
September 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Blastocoele re-expansion degree
Defined as the degree of blastocoele re-expansion and presented in %
Two hours post thawing
Pregnancy rate
Defined as clinical pregnancy per transfer
15 days post embryo transfer
Implantation rate
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
6-8 weeks of pregnancy
Blastocyst survival rate
Defined as the proportion of blastocysts that showed expansion degree ≥50% and their cells remained intact after thawing and re-expansion
Two hours post thawing
Eligibility Criteria
ICSI cases that have planned to do PGT-A for their blastocysts, oocytes were cultured in time lapse incubators from day 0-6. Female aged between 18 and 45 years old can be included. PGT-A was done using next generation sequencing (NGS) platform and their results were confirmed using PGT-ai.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ganin Fertility Center
Cairo, 11728, Egypt
Biospecimen
Trophoectoderm samples were taken from day 5 or 6 blastocysts for PGT-A
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eman Hasanen, BSc.
Ganin Fertility Center
- PRINCIPAL INVESTIGATOR
Manar Hozayen, MSc.
Ganin Fertility Center
- PRINCIPAL INVESTIGATOR
Amr Elshimy, BSc.
Ganin Fertility Center
- PRINCIPAL INVESTIGATOR
Hanaa Alkhader
Ganin Fertility Center
- STUDY DIRECTOR
Hosam Zaki, MSc, FRCOG
Ganin Fertility Center
- PRINCIPAL INVESTIGATOR
Samar Gamal, BP
Ganin Fertility Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Embryologist
Study Record Dates
First Submitted
August 11, 2022
First Posted
August 12, 2022
Study Start
August 7, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
September 22, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP