Use of Time-lapse Morphological Kinetics in the Selection of Blastocysts
Embryoscope
Does Use of Time-lapse Morphological Kinetics in the Selection of Blastocysts for Transfer Improve Pregnancy Rates?
1 other identifier
interventional
300
1 country
1
Brief Summary
This is a randomized controlled observational trial to determine if data obtained from the embryoscope is helpful in determining which blastocysts to transfer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2014
CompletedFirst Posted
Study publicly available on registry
March 7, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
May 15, 2017
CompletedJune 8, 2017
May 1, 2017
1.8 years
March 5, 2014
February 6, 2017
May 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Pregnancy Rate
Patients will have a ultrasound to document fetal heart rate approximately 6 weeks after start of IVF cycle.
6 weeks
Secondary Outcomes (1)
Implantation Rate
6 weeks
Study Arms (2)
Conventional grading
PLACEBO COMPARATOREmbryos will be scored based on conventional criteria.
Embryoscope data
ACTIVE COMPARATOREmbryos will be scored based on both conventional rating and embryoscope data.
Interventions
The embryoscope is a microscope that allows for continuous time-lapse monitoring.
Eligibility Criteria
You may qualify if:
- Patients undergoing an IVF cycle between the age of 18-45 at the Cleveland Clinic Reproductive Endocrinology and Infertility clinic with the plan for transfer of embryo(s) will be offered the opportunity to participate in this study.
You may not qualify if:
- The only patients excluded will be those undergoing pre-implantation genetic testing and/or chromosome screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic Beachwood Family Health Center
Beachwood, Ohio, 44122, United States
Related Publications (1)
Goodman LR, Goldberg J, Falcone T, Austin C, Desai N. Does the addition of time-lapse morphokinetics in the selection of embryos for transfer improve pregnancy rates? A randomized controlled trial. Fertil Steril. 2016 Feb;105(2):275-85.e10. doi: 10.1016/j.fertnstert.2015.10.013. Epub 2015 Oct 29.
PMID: 26522611DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lynn Borzi (Research Administrator)
- Organization
- Cleveland Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Desai, PhD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2014
First Posted
March 7, 2014
Study Start
April 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
June 8, 2017
Results First Posted
May 15, 2017
Record last verified: 2017-05