NCT05499988

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

August 11, 2022

Last Update Submit

September 21, 2022

Conditions

Keywords

Blastocyst diameterPGT-ATime lapseBlastocyst survivalTE biopsy

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

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

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

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Trophoectoderm samples were taken from day 5 or 6 blastocysts for PGT-A

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Hosam Zaki, MSc, FRCOG

    Ganin Fertility Center

    STUDY DIRECTOR
  • Samar Gamal, BP

    Ganin Fertility Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Hasanen, BSc.

CONTACT

Manar Hozayen, MSc.

CONTACT

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

Locations