In Vitro Human Embryo Culture System
1 other identifier
interventional
40
1 country
4
Brief Summary
The purpose of this study is to compare the development of human embryos grown in a conventional culture dish to those grown in a new embryo culture device known as the SMART System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2009
4 active sites
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
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedSeptember 9, 2010
September 1, 2010
10 months
September 25, 2009
September 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of development of human embryos
Day 3 (t=72 hrs)
Study Arms (2)
experimental arm
EXPERIMENTALEmbryos cultured in SMART System
Control
ACTIVE COMPARATOREmbryos cultured in microdrops in dishes
Interventions
microfluidic embryo culture system
Eligibility Criteria
You may qualify if:
- Female 21 to 35 years of age inclusive
- First or second IVF cycle
- Not pregnant
- No physical abnormalities that would adversely affect oocyte retrieval
- Male factor is acceptable
- ICSI is acceptable
- zygotes or more
You may not qualify if:
- The sperm were retrieved using TESE or MESA
- The embryos were created with either donor oocytes or donor sperm.
- Medical condition precluding a safe pregnancy
- Medical condition disqualifying the subject from safely participating in the study in the judgment of the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Pacific Fertility Center
San Francisco, California, 94133, United States
Florida Fertility Institute
Clearwater, Florida, 33759, United States
Southeastern Fertility Center
Mt. Pleasant, South Carolina, 29464, United States
Fertility Center of San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas B Pool, Ph.D., HCLD
Fertility Center of San Antonio
- PRINCIPAL INVESTIGATOR
Joseph Conaghan, Ph.D., HCLD
Pacific Fertility Center
- PRINCIPAL INVESTIGATOR
Rodney Wade, BSA, MS, ELD
Southeastern Fertility Center
- PRINCIPAL INVESTIGATOR
Kelvin L Fry, B. SC.
Florida Fertility Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 28, 2009
Study Start
November 1, 2009
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
September 9, 2010
Record last verified: 2010-09