InfertilityNCT04485910
PGTai Results for Embryos Cultured in Sequential Versus Single Step Media
A study testing Single step media and Sequential media in people with Infertility and Aneuploidy Rate, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
A prospective cohort study undergoing ICSI at a private fertility center in Egypt Read more about this study
- Who is it for?
- Ages 18 to 37 years
- Conditions the study is for
- Infertility, Aneuploidy Rate, Mosaicism
- What is being tested?
- Single step media and Sequential media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 1 Jun 2021
- Phase
- Interventional
- 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 37 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female age ≤37 years with ≥ 8 mature oocytes
- Male partner had normal semen parameters according to WHO 2010
- PGT-A was done at the blastocyst stage
Who cannot join
- sperm or oocyte donor
- severe male factors according to WHO 2010
Trial locations and contacts
1 site in 1 country.
Amr Elshimy, BSc. contact
About this study
Official title: Sequential Versus Single Step Culture Media in Relation to Euploidy Rates in PGTai Program
A prospective cohort study undergoing ICSI at a private fertility center in Egypt
Read the detailed description
Purpose:
To evaluate PGTai results for embryos cultured in sequential versus single step media.
Method:
Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10% SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage and blastocyst media with 10% SPS (SAGE, Denmark).
All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go through PGTA procedures with PGTai confirmation.
- Conditions
- Infertility, Aneuploidy Rate, Mosaicism
- Being tested
- Single step media, Sequential media
- Keywords
- PGT-A, Mosaicism, Single step media, Sequential media
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single step mediaOther
Usage of single step media in embryo culture
Sequential mediaOther
Usage of sequential media in embryo culture
| Study group | Role | What they receive |
|---|---|---|
| Single step media | Active comparator | Embryos cultured in single step media Receives: Other: Single step media |
| Sequential media | Active comparator | Embryos cultured in sequential media Receives: Other: Sequential media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Euploidy rate
percentage of euploid embryos/ total genetic tested embryos on blast stage
Measured: 5:7 days of intracytoplasmic sperm injection(ICSI)
Mosaicism rate
percentage of mosaic embryos/ total genetic tested embryos on blast stage
Measured: 5:7 days of ICSI
Secondary outcomes (5)
Fertilization rate
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
Measured: 16:19 hours of ICSI
Cleavage stage
Percentage of cleaved embryos/ total number of fertilized oocytes
Measured: 72 hours of ICSI
High quality of cleaved embryos
High quality D3 embryos according to Gardner's criteria / total cleaved embryos
Measured: 72 hours of ICSI
Blast formation rate
Percentage of total blastocysts / Total cleaved embryos
Measured: 5:7 days of ICSI
High quality blast rate
Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.
Measured: 5:7 days of ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Dec 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Jun 2021 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manar M Hozyen, MSc., Principal investigator, Ganin Fertility CenterAmr Elshimy, BSc., Principal investigator, Ganin Fertility CenterHanaa Elkhader, BSc., Principal investigator, Ganin Fertility CenterHosam Zaki, MSc., Study chair, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485910
- Sponsor's protocol ID
- MH0004
- Status last verified
- Jun 2020
- First submitted
- 22 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Versus Single Step Culture Media in Relation to Euploidy Rates in PGTai Program
- ClinicalTrials.gov ID
- NCT04485910
- Acronym / sponsor ID
- MH0004
- Conditions
- Infertility, Aneuploidy Rate, Mosaicism
- Keywords
- PGT-A, Mosaicism, Single step media, Sequential media
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 24 Jul 2020 (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.
A prospective cohort study undergoing ICSI at a private fertility center in Egypt
Detailed description
Purpose:
To evaluate PGTai results for embryos cultured in sequential versus single step media.
Method:
Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10% SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage and blastocyst media with 10% SPS (SAGE, Denmark).
All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go through PGTA procedures with PGTai confirmation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
| Arm | Type | Receives |
|---|---|---|
| Single step media | Active comparator | Other: Single step mediaEmbryos cultured in single step media |
| Sequential media | Active comparator | Other: Sequential mediaEmbryos cultured in sequential media |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female age ≤37 years with ≥ 8 mature oocytes
- Male partner had normal semen parameters according to WHO 2010
- PGT-A was done at the blastocyst stage
Key exclusion criteria (2 listed)
- sperm or oocyte donor
- severe male factors according to WHO 2010
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single step mediaUsage of single step media in embryo culture | Other | Single step media |
| Sequential mediaUsage of sequential media in embryo culture | Other | Sequential media |
Primary outcome
Euploidy rate
Time frame: 5:7 days of intracytoplasmic sperm injection(ICSI)
percentage of euploid embryos/ total genetic tested embryos on blast stage
Mosaicism rate
Time frame: 5:7 days of ICSI
percentage of mosaic embryos/ total genetic tested embryos on blast stage
5 secondary outcomes
Fertilization rate
Time frame: 16:19 hours of ICSI
Cleavage stage
Time frame: 72 hours of ICSI
High quality of cleaved embryos
Time frame: 72 hours of ICSI
Blast formation rate
Time frame: 5:7 days of ICSI
High quality blast rate
Time frame: 5:7 days of ICSI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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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.
Amr Elshimy, BSc. contact
Manar M Hozyen, MSc. principal investigator
Ganin Fertility Center
Amr Elshimy, BSc. principal investigator
Ganin Fertility Center
Hanaa Elkhader, 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?
A study testing Single step media and Sequential media in people with Infertility and Aneuploidy Rate, 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 3 inclusion and 2 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 24 Jul 2020. 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 Manar M Hozyen, MSc. (+201229483320, manarnrc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Euploidy rate (time frame: 5:7 days of intracytoplasmic sperm injection(ICSI)). The study lists 2 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 24 Jul 2020.