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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499988
• Other study ID #: GFC-006
• Status: Recruiting
• Start date: August 7, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Ganin Fertility Center
• Contact: Eman Hasanen, BSc.
• Phone: 01282012291
• Email: em.saber[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastocoele re-expansion degree	Defined as the degree of blastocoele re-expansion and presented in %	Two hours post thawing
Primary	Pregnancy rate	Defined as clinical pregnancy per transfer	15 days post embryo transfer
Primary	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
Primary	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