Clinical trial NCT05499988: The Importance of Blastocyst Diamater and Its Correlation to Reproductive Outcomes in PGT-A Cases
Official title: The Importance of Blastocyst Diamater and Its Correlation to Reproductive Outcomes in PGT-A Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: Blastocyst diameter
PGT-A
Time lapse
Blastocyst survival
TE biopsy
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blastocoele re-expansion degree
timeFrame: Two hours post thawing
measure: Pregnancy rate
timeFrame: 15 days post embryo transfer
measure: Implantation rate
timeFrame: 6-8 weeks of pregnancy
measure: Blastocyst survival rate
timeFrame: Two hours post thawing
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
Study officials:
affiliation: Ganin Fertility Center
name: Eman Hasanen, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Manar Hozayen, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Amr Elshimy, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hanaa Alkhader
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, MSc, FRCOG
role: STUDY_DIRECTOR
affiliation: Ganin Fertility Center
name: Samar Gamal, BP
role: PRINCIPAL_INVESTIGATOR
References: