InfertilityNCT05499988
The Importance of Blastocyst Diamater and Its Correlation to Reproductive Outcomes in PGT-A Cases
An observational study of Infertility, run by Ganin Fertility Center at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Infertility
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Aug 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ganin Fertility Center
Cairo, 11728
Hosam Zaki, 16270, hosamz@tedata.net.eg
About this study
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.
Read the 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.
- Conditions
- Infertility
- Keywords
- Blastocyst diameter, PGT-A, Time lapse, Blastocyst survival, TE biopsy
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocoele re-expansion degree
Defined as the degree of blastocoele re-expansion and presented in %
Measured: Two hours post thawing
Pregnancy rate
Defined as clinical pregnancy per transfer
Measured: 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.
Measured: 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
Measured: Two hours post thawing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start7 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hasanen, Ganin Fertility Center
- Investigators
- Eman Hasanen, BSc., Principal investigator, Ganin Fertility CenterManar Hozayen, MSc., Principal investigator, Ganin Fertility CenterAmr Elshimy, BSc., Principal investigator, Ganin Fertility CenterHanaa Alkhader, Principal investigator, Ganin Fertility CenterHosam Zaki, MSc, FRCOG, Study director, Ganin Fertility CenterSamar Gamal, BP, Principal investigator, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499988
- Sponsor's protocol ID
- GFC-006
- Status last verified
- Sep 2022
- First submitted
- 11 Aug 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Blastocyst Diamater and Its Correlation to Reproductive Outcomes in PGT-A Cases
- ClinicalTrials.gov ID
- NCT05499988
- Acronym / sponsor ID
- GFC-006
- Conditions
- Infertility
- Keywords
- Blastocyst diameter, PGT-A, Time lapse, Blastocyst survival, TE biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 7 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blastocoele re-expansion degree
Time frame: Two hours post thawing
Defined as the degree of blastocoele re-expansion and presented in %
Pregnancy rate
Time frame: 15 days post embryo transfer
Defined as clinical pregnancy per transfer
Implantation rate
Time frame: 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.
Blastocyst survival rate
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Hasanen, BSc. principal investigator
Ganin Fertility Center
Manar Hozayen, MSc. principal investigator
Ganin Fertility Center
Amr Elshimy, BSc. principal investigator
Ganin Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ganin Fertility Center at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Hasanen, BSc. (01282012291, em.saber@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocoele re-expansion degree (time frame: Two hours post thawing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022; AzTrials last refreshed its copy on 8 Nov 2026.