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

Recruiting

• Conditions: Infertility

• Registration Number: NCT05499988
• Lead Sponsor: Ganin Fertility Center

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-08-07
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blastocoele re-expansion degree	Two hours post thawing	Defined as the degree of blastocoele re-expansion and presented in %
Implantation rate	6-8 weeks of pregnancy	Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred.
Pregnancy rate	15 days post embryo transfer	Defined as clinical pregnancy per transfer
Blastocyst survival rate	Two hours post thawing	Defined as the proportion of blastocysts that showed expansion degree ≥50% and their cells remained intact after thawing and re-expansion

Trial Locations

Locations (1)

Ganin Fertility Center; 🇪🇬 Cairo, Egypt