Can Time-lapse Parameters be Used to Predict Pregnancy of Human Embryos?
NCT ID: NCT03445923
Last Updated: 2021-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
776 participants
INTERVENTIONAL
2018-05-29
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
METHODS AND MATERIAL IVF procedure Oocytes retrieved 36±1h after hCG administration will be fertilized by either standard insemination or ICSI. The morning after oocyte retrieval (day 1) zygotes will be placed into embryo time-lapse slides for culture up to the day of transfer (day 5). During the culture time, embryos will be kept in commercially available culture media and will not be removed from the time-lapse incubator until day of transfer. Embryos interact with the media and will be allowed to develop the blastocyst stage (5-6 days culture) at which time selection for transfer will be made. During the in vitro culture a single image captured in the time-lapse incubator will be used to routinely morphologically grade embryos, according to the Istanbul consensus. On day 5, developing embryos will be assessed (according to study vs. control group criteria) to select the embryo for transfer into the patient. Supernumerous GQE will be cryopreserved for future use.
Time-lapse photography All embryos will be placed in wells of time-lapse culture dishes (Embryoscope) according to the instructions of the manufacturer. Embryos in both groups will be cultured to the blastocyst stage without any media change. The time-lapse system is comprised of a desktop incubator that controls it´s environment (pH, CO2 and O2) as well as taking pictures in up to 11 focal planes for the whole duration of the culture periods.
Morphological scoring Embryo morphology will be scored according to the Gardner score and then translated to the Istanbul consensus system if needed for publication.
To assure that all embryologists annotate the embryo development correctly as well as score the blastocysts in the same way, a validation process will be performed before the onset of the study. The standardization will be accomplished through a process where the embryologists will score 20 blastocysts at day 5-development stage, which will be provided on a CD, imitating the procedure will be performed routinely in the laboratory. The embryologists will have to be approved in order to be allowed to score embryos in the study.
Embryo evaluation (both groups). Embryos will be cultured in the Embryoscope time-lapse system until day 5. If two or more blastocyst of good quality (GQB), i.e. fulfilling a minimum morphological criteria of 3BB or better, develop, a preliminary decision is made on which embryo to select for transfer. Thereafter the couple is randomized into either the control or the time-lapse group.
Decision making in the time-lapse group If the couple is randomized into the time-lapse group all embryos that have reached the blastocyst stage will be annotated. The blastocyst with the highest KID (day 5) score will be chosen for transfer. To ensure a reliable KID scores can be attained the morphological events; time to 2, 3, 4, and 5 cells, time to start of blastulation (tSB), and TE scores must be evaluated.
Decision making in the control group If the couple are randomized to the control group, the preliminary embryo selection decision will be maintained.
Study monitoring. A Data Study Monitoring Board (DSMB) Group will be assigned and have the task of conducting both safety checks and an interim analysis (planned when ca 50% of the patients have been recruited).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Morphology
Embryos for transfer will be selected based on standard morphological evaluation.
No interventions assigned to this group
TLM
Embryos for transfer will be selected base on standard morphological evaluation and information from time-lapse monitoring.
Time lapse monitoring (KID Score)
The unique information that is obtainable from taking Pictures each 10 minutes throughout the development of the embryos will be used in the form of a special score (KID score). The score is comprised out of several key developmental parameters.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Time lapse monitoring (KID Score)
The unique information that is obtainable from taking Pictures each 10 minutes throughout the development of the embryos will be used in the form of a special score (KID score). The score is comprised out of several key developmental parameters.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* On day 5, before the randomization the couple must have at least 2 transferrable blastocysts in order to be included in the study.
* If double embryo transfer, for any reason, is planned.
* Prior participation in the study.
* Pre-implantation genetic diagnosis (PGD) treatment.
* Embryo transfer on another day than day 5.
* Oocyte cryopreservation.
* Planned total freeze of embryos for any reason (cancer, OHSS etc.)
20 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fertilitetscentrum AB
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Thorir Hardarson
Laboratory Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Livio Reykjavik
Reykjavik, , Iceland
Livio Oslo
Oslo, , Norway
Livio Falun
Falun, , Sweden
Fertilitetscentrum Livio Göteborg
Gothenburg, , Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Livio Malmö
Malmo, , Sweden
Karolinska Universtetssjukhuset
Stockholm, , Sweden
Livio Gärdet
Stockholm, , Sweden
Livio Kungsholmen
Stockholm, , Sweden
Sophiahemmet
Stockholm, , Sweden
Livio Umeå
Umeå, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ahlstrom A, Lundin K, Lind AK, Gunnarsson K, Westlander G, Park H, Thurin-Kjellberg A, Thorsteinsdottir SA, Einarsson S, Astrom M, Lofdahl K, Menezes J, Callender S, Nyberg C, Winerdal J, Stenfelt C, Jonassen BR, Oldereid N, Nolte L, Sundler M, Hardarson T. A double-blind randomized controlled trial investigating a time-lapse algorithm for selecting Day 5 blastocysts for transfer. Hum Reprod. 2022 Apr 1;37(4):708-717. doi: 10.1093/humrep/deac020.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
954-17
Identifier Type: -
Identifier Source: org_study_id