AneuploidyNCT04901247
A Time-lapse Monitoring Prospective Study
An observational study of Aneuploidy and Infertility, run by ART Fertility Clinics LLC at 2 sites in United Arab Emirates.
Trial summary
While numerous types of commercially available human embryo culture media exist for human blastocyst culture, the impact of culture conditions on blastocyst development and aneuploidy formation is not fully understood. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Aneuploidy, Infertility
- What is being tested?
- media refreshment and embryo grading
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 6 Jul 2021to 30 Dec 2023
- How long will I take part?
- 7 Days
- 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 40 years
- Women only
- Adult
Study population: Patients undergoing a fertility treatment due to primary or secondary infertility at ART Fertility Clinics.
Who may be able to join
- Patients with a minimum of 8 - 10 follicles during ovarian stimulation
- Patients with a minimum of 8 mature oocytes
- PGT-A
- ICSI
- BMI<35
- Age 18- 40
Show all 9Show fewer
- Fresh or frozen ejaculatory sperm >10,000 motile sperm
- Any Ovarian stimulation
- Embryos cultured in Time-lapse system
Who cannot join
- PGT-M or PGT-SR
- Previous history of embryo arrest
- Endometriosis
- Hydrosalpinx
- History of uterine abnormality or previous uterine surgery
- History of previous treatment which may impact the ovarian reserve (adnexal surgery, chemotherapy, radiation…)
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites
ART Fertility Clinics
Abu Dhabi
Ibrahim Elkhatib
Abu Dhabi
About this study
Official title: Exploring Single Step Culture Medium Refreshment Effect on Embryo Ploidy Rate: A Time-lapse Monitoring Prospective Study
While numerous types of commercially available human embryo culture media exist for human blastocyst culture, the impact of culture conditions on blastocyst development and aneuploidy formation is not fully understood. Culture conditions are very important for the success of the in vitro fertilization (IVF) cycle, many of the factors involved in the process have been extensively studied. However, none of the studies investigated the effect on euploid rate in a sibling oocyte design with preimplantation genetic testing for aneuploidy (PGT-A), which requires culture till day 7. In addition, the clinical outcome (implantation) will be investigated in a frozen cycle regimen. Hence, the study will explore which day of media refreshment will result in higher rate of ploidy and would improve clinical outcomes. Investigators aim at exploring the best practice, that would empower the euploid rate through the comparison of refreshing the single-step medium on day 3 or day 5 in a sibling oocyte prospective design.
Read the detailed description
The use of extended embryo culture to the blastocyst stage and PGT-A has enabled identification and selection of embryos with the best developmental potential and improved IVF clinical outcomes. It is considered a routine practice to grade the embryos on day 3 of development, which will require disturbing the culture conditions by annotating the embryos using inverted microscopes. However, the application of Time-lapse technology (TLS) allows annotating the embryos on day 3 without interrupting the culture conditions, especially if TLS is combined with single-step culture medium.
There are several culture factors that can affect embryo development, such as the pH, which is controlled through the concentration of CO2, and also the osmolality, which is the concentration of solute per liter of solution. Evaporation of the solution due to the exposure to high temperature (37°C) can change the concentrations and hence compromise embryo development.
Since single-step medium is designed to sustain embryo development for 5 continuous culture days, while some laboratories culture embryos for 7 days, refreshing the culture medium is inevitable either on day 3 or day 5 of development.
There is no concrete evidence on which of these practices will provide a better environment for embryo development. Moreover, none of the studies investigated the effect of single-step culture medium changeover on day 3 or day 5, on the chromosomal errors (aneuploidy). We aim in this study to explore which day of culture medium refreshment (day 3 or day 5) provides a higher rate of euploid blastocysts.
Summary about data collected. Categorical data will be presented in frequency tables and histograms. Continuous values will be summarized according the mean, standard deviation and confidence interval.
- Conditions
- Aneuploidy, Infertility
- Being tested
- media refreshment, embryo grading
- Keywords
- infertility, ivf, embryo, embryoscope, culture media, aneuploidy
- Medical subject headings
- Aneuploidy, Infertility, Long Qt Syndrome 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
media refreshmentBehavioural
20µL of culture medium is aspirated using Eppendorf PCR tips, and freshly, overnight equilibrated 20µL global total LP will be added to the same well
embryo gradingBehavioural
embryo grading should be done prior to media refreshment
| Study group | Role | What they receive |
|---|---|---|
| day 3 | embryo grading and culture refreshment will be done 67-69 hours post insemination Receives: Behavioral: media refreshment; Behavioral: embryo grading | |
| day 5 | embryo grading and culture medium refreshment will be done 114-118 hours post insemination Receives: Behavioral: media refreshment; Behavioral: embryo grading |
What is being measured
The primary outcome is the main question the study is designed to answer.
blastocyst ploidy
determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development.
Measured: 3 days
Secondary outcomes (4)
cycle ploidy rate
the number of euploid embryos in the group divided by the total number of 2PN
Measured: 1 day
mosaicism frequency
defined as the rate of mosaic errors in aneuploid embryos. This includes full mosaic embryos or aneuploid embryos with 1 or more mosaic chromosome aberration
Measured: 1 day
blastocyst quality at time of biopsy
Four Embryo Quality Scores (EQ1, 2, 3, 4) based on the expansion stage of the blastocyst, the grade of the inner cell mass and the grade of the trophectoderm
Measured: 1 day
blastulation rate
ability of the embryo to form a cavity (=to blastulate) 118hours post ICSI. Number of blastocysts divided by the number of 2PN
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start6 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AneuploidyStudies 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
- 50 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Elkhatib, ART Fertility Clinics LLC
- Investigators
- IBRAHIM ELKHATIB, Principal investigator, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901247
- Sponsor's protocol ID
- 2103-ABU-003-IK
- Status last verified
- Mar 2023
- First submitted
- 20 May 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bavister BD, Poole KA. Duration and temperature of culture medium equilibration affect frequency of blastocyst development. Reprod Biomed Online. 2005 Jan;10(1):124-9. doi: 10.1016/s1472-6483(10)60813-9.
PubMed 15705308Costa-Borges N, Belles M, Meseguer M, Galliano D, Ballesteros A, Calderon G. Blastocyst development in single medium with or without renewal on day 3: a prospective cohort study on sibling donor oocytes in a time-lapse incubator. Fertil Steril. 2016 Mar;105(3):707-713. doi: 10.1016/j.fertnstert.2015.11.038. Epub 2015 Dec 12.
PubMed 26690010Krasnopolskaya KV, Beketova AN, Sesina NI, capital ES, Cyrillichinchenko NK, Badalyan GV, Sudarikova NM, Bocharova TV, Zakharchenko EO. The effect of short-term disturbance of day 3 embryo culture on the development and implantation. Gynecol Endocrinol. 2019;35(sup1):1-4. doi: 10.1080/09513590.2019.1632083.
PubMed 31532309
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Single Step Culture Medium Refreshment Effect on Embryo Ploidy Rate: A Time-lapse Monitoring Prospective Study
- ClinicalTrials.gov ID
- NCT04901247
- Acronym / sponsor ID
- 2103-ABU-003-IK
- Conditions
- Aneuploidy, Infertility
- Keywords
- infertility, ivf, embryo, embryoscope, culture media, aneuploidy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 25 May 2021 (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.
While numerous types of commercially available human embryo culture media exist for human blastocyst culture, the impact of culture conditions on blastocyst development and aneuploidy formation is not fully understood. Culture conditions are very important for the success of the in vitro fertilization (IVF) cycle, many of the factors involved in the process have been extensively studied. However, none of the studies investigated the effect on euploid rate in a sibling oocyte design with preimplantation genetic testing for aneuploidy (PGT-A), which requires culture till day 7. In addition, the clinical outcome (implantation) will be investigated in a frozen cycle regimen. Hence, the study will explore which day of media refreshment will result in higher rate of ploidy and would improve clinical outcomes. Investigators aim at exploring the best practice, that would empower the euploid rate through the comparison of refreshing the single-step medium on day 3 or day 5 in a sibling oocyte prospective design.
Detailed description
The use of extended embryo culture to the blastocyst stage and PGT-A has enabled identification and selection of embryos with the best developmental potential and improved IVF clinical outcomes. It is considered a routine practice to grade the embryos on day 3 of development, which will require disturbing the culture conditions by annotating the embryos using inverted microscopes. However, the application of Time-lapse technology (TLS) allows annotating the embryos on day 3 without interrupting the culture conditions, especially if TLS is combined with single-step culture medium.
There are several culture factors that can affect embryo development, such as the pH, which is controlled through the concentration of CO2, and also the osmolality, which is the concentration of solute per liter of solution. Evaporation of the solution due to the exposure to high temperature (37°C) can change the concentrations and hence compromise embryo development.
Since single-step medium is designed to sustain embryo development for 5 continuous culture days, while some laboratories culture embryos for 7 days, refreshing the culture medium is inevitable either on day 3 or day 5 of development.
There is no concrete evidence on which of these practices will provide a better environment for embryo development. Moreover, none of the studies investigated the effect of single-step culture medium changeover on day 3 or day 5, on the chromosomal errors (aneuploidy). We aim in this study to explore which day of culture medium refreshment (day 3 or day 5) provides a higher rate of euploid blastocysts.
Summary about data collected. Categorical data will be presented in frequency tables and histograms. Continuous values will be summarized according the mean, standard deviation and confidence interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| day 3 | – | Behavioral: media refreshment, Behavioral: embryo gradingembryo grading and culture refreshment will be done 67-69 hours post insemination |
| day 5 | – | Behavioral: media refreshment, Behavioral: embryo gradingembryo grading and culture medium refreshment will be done 114-118 hours post insemination |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients undergoing a fertility treatment due to primary or secondary infertility at ART Fertility Clinics.
Key inclusion criteria (9 listed)
- Patients with a minimum of 8 - 10 follicles during ovarian stimulation
- Patients with a minimum of 8 mature oocytes
- PGT-A
- ICSI
- BMI<35
Key exclusion criteria (6 listed)
- PGT-M or PGT-SR
- Previous history of embryo arrest
- Endometriosis
- Hydrosalpinx
- History of uterine abnormality or previous uterine surgery
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 |
|---|---|---|
| media refreshment20µL of culture medium is aspirated using Eppendorf PCR tips, and freshly, overnight equilibrated 20µL global total LP will be added to the same well | Behavioural | day 3, day 5 |
| embryo gradingembryo grading should be done prior to media refreshment | Behavioural | day 3, day 5 |
Primary outcome
blastocyst ploidy
Time frame: 3 days
determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development.
4 secondary outcomes
cycle ploidy rate
Time frame: 1 day
mosaicism frequency
Time frame: 1 day
blastocyst quality at time of biopsy
Time frame: 1 day
blastulation rate
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Background: PubMed 15705308Bavister BD, Poole KA. Duration and temperature of culture medium equilibration affect frequency of blastocyst development. Reprod Biomed Online. 2005 Jan;10(1):124-9. doi: 10.1016/s1472-6483(10)60813-9.
- Background: PubMed 26690010Costa-Borges N, Belles M, Meseguer M, Galliano D, Ballesteros A, Calderon G. Blastocyst development in single medium with or without renewal on day 3: a prospective cohort study on sibling donor oocytes in a time-lapse incubator. Fertil Steril. 2016 Mar;105(3):707-713. doi: 10.1016/j.fertnstert.2015.11.038. Epub 2015 Dec 12.
- Background: PubMed 31532309Krasnopolskaya KV, Beketova AN, Sesina NI, capital ES, Cyrillichinchenko NK, Badalyan GV, Sudarikova NM, Bocharova TV, Zakharchenko EO. The effect of short-term disturbance of day 3 embryo culture on the development and implantation. Gynecol Endocrinol. 2019;35(sup1):1-4. doi: 10.1080/09513590.2019.1632083.
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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.
IBRAHIM ELKHATIB principal investigator
ART Fertility Clinics LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneuploidy and Infertility, run by ART Fertility Clinics LLC at 2 sites in United Arab Emirates.
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 9 inclusion and 6 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blastocyst ploidy (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901247, which also lists 3 linked publications.
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 Mar 2023.