A Benchtop Incubator Prospective Study
Exploring Single Step Culture Medium Refreshment Effect on Embryo Ploidy Rate: A Benchtop Incubator Prospective Study
1 other identifier
observational
50
1 country
1
Brief Summary
The use of extended embryo culture to the blastocyst stage and preimplantation genetic testing for aneuploidy (PGT-A) has enabled identification and selection of embryos with the best developmental potential and improved in vitro fertilization (IVF) clinical outcomes. While numerous types of commercially available human embryo culture media exist for culture to the blastocyst stage, the impact of culture conditions on blastocyst development and aneuploidy formation is not well understood. Culture conditions are very important for the success of the IVF cycle, many of the factors involved in the process have been extensively studied, including the use of sequential culture medium vs single step culture medium, humidified incubators vs dry incubators and refreshing the medium on day 3 vs uninterrupted culture till day 5. However, none of the studies investigated the effect on euploid rate in a sibling oocyte design with PGT-A, which requires culture till day 7.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 24, 2023
March 1, 2023
2 years
July 11, 2021
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blastocyst ploidy
determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development
3 days
Secondary Outcomes (4)
Cycle ploidy rate
1 day
Mosaicism Frequency
1 day
Blastocyst quality at time of biopsy
1 day
Blastulation rate
5 days
Study Arms (2)
day 3 refreshment
All MII oocytes will be inseminated by ICSI 39-41 hours post final oocyte maturation trigger. Following ICSI, oocytes will be cultured in 2-4 culture dishes placed in 2 separate chambers. Media refreshment: Zygote scoring on day 1 (18-20hpi). Culture medium refreshment will be done 67-69 hours post insemination (Day3). Embryo grading will not be done day2-5. Culture media preparation and refreshment: 30µL of culture medium (Global total LP is added to each well of the 8 wells of LifeGlobal GPS Dish (EGPS-010) and 50µL to the center 3 drops. Dishes will be equilibrated overnight in a CO2 incubator. Embryo grading should be done prior to media refreshment. Time out of the incubator during media refreshment will be assessed on day 3 and day 5. One operator should perform the ICSI. In case of multiple operators, each operator's injected oocytes will be split between the 2 groups.
day 5 refreshment
All MII oocytes will be inseminated by ICSI 39-41 hours post final oocyte maturation trigger. Following ICSI, oocytes will be cultured in 2-4 culture dishes placed in 2 separate chambers. Media refreshment and embryo grading timings: Zygote scoring on day 1 (18-20hpi). Embryo grading and culture media refreshment will be done 114-118 hours post insemination (Day5). Culture media preparation and refreshment: 30µL of culture medium (Global total LP is added to each well of the 8 wells of LifeGlobal GPS Dish (EGPS-010) and 50µL to the center 3 drops. Dishes will be equilibrated overnight in a CO2 incubator. Embryo grading and media refreshment is done prior to blastocyst biopsy. Time out of the incubator during media refreshment will be assessed on day 3 and day 5. One operator should perform the ICSI. In case of multiple operators, each operator's injected oocytes will be split between the 2 groups.
Interventions
All MII oocytes will be inseminated by ICSI 39-41 hours post final oocyte maturation trigger.
Zygote scoring on day 1 (18-20hpi). Culture medium refreshment will be done 67-69 hours post insemination (Day3).
30µL of culture medium (Global total LP is added to each well of the 8 wells of LifeGlobal GPS Dish (EGPS-010) and 50µL to the center 3 drops. Dishes will be equilibrated overnight in a CO2 incubator.
Should be done prior to media refreshment. For group 2, embryo grading and media refreshment is done prior to blastocyst biopsy.
Zygote scoring on day 1 (18-20hpi). Culture media refreshment will be done 114-118 hours post insemination (Day5).
Eligibility Criteria
The study is eligible to all patients, meeting the inclusion criteria, undergoing a fertility treatment with PGT-A analysis at the blastocyst stage
You may qualify if:
- 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
- Fresh or frozen ejaculated sperm \>10,000 motile sperm
- Any ovarian stimulation
- Embryos cultured in benchtop incubator
You may not qualify if:
- PGT-M or PGT-SR
- Previous history of embryo arrest
- Endometriosis
- History of previous treatment which may impact the ovarian reserve (adnexal surgery, chemotherapy, radiation…)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ART Fertility Clinics LLC
Abu Dhabi, 60202, United Arab Emirates
Related Publications (4)
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.
PMID: 15705308BACKGROUNDCosta-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.
PMID: 26690010BACKGROUNDPena F, Davalos R, Rechkemmer A, Ascenzo A, Gonzales M. Embryo development until blastocyst stage with and without renewal of single medium on day 3. JBRA Assist Reprod. 2018 Mar 1;22(1):49-51. doi: 10.5935/1518-0557.20180012.
PMID: 29318868BACKGROUNDKrasnopolskaya 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.
PMID: 31532309BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
IBRAHIM ELKHATIB
ART Fertility Clinics LLC
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 11, 2021
First Posted
July 20, 2021
Study Start
July 15, 2021
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
March 24, 2023
Record last verified: 2023-03