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

Sponsor
Ganin Fertility Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05499988
Collaborator
(none)
1,000
Enrollment
1
Location
16.8
Anticipated Duration (Months)
59.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Importance of Blastocyst Diamater and Its Correlation to Reproductive Outcomes in PGT-A Cases
    Actual Study Start Date :
    Aug 7, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Blastocoele re-expansion degree [Two hours post thawing]

      Defined as the degree of blastocoele re-expansion and presented in %

    2. Pregnancy rate [15 days post embryo transfer]

      Defined as clinical pregnancy per transfer

    3. 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.

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ganin Fertility Center Cairo Egypt 11728

    Sponsors and Collaborators

    • Ganin Fertility Center

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eman Hasanen, Embryologist, Ganin Fertility Center
    ClinicalTrials.gov Identifier:
    NCT05499988
    Other Study ID Numbers:
    • GFC-006
    First Posted:
    Aug 12, 2022
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eman Hasanen, Embryologist, Ganin Fertility Center
    Blastocyst diameter
    PGT-A
    Time lapse
    Blastocyst survival
    TE biopsy
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Aug 12, 2022