Back to resultsComparison of Alternative Embryo Culture Systems
Primary Purpose
Infertility
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional embryo culture
Enclosed embryo culture
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring In vitro fertilization, IVF, Embryo culture, Blastocyst transfer
Eligibility Criteria
Inclusion Criteria:
- Female age 18 to 40, seeking IVF treatment
- Ability to understand English (to obtain informed consent)
- Use of an oocyte donor, sperm donor, gestational carrier, and/or genetic testing (with blastocyst biopsy only) are allowed.
Exclusion Criteria:
- Diminished ovarian reserve as evidenced by either elevated cycle day 3 follicle stimulating hormone (FSH) level (≥10 IU/L) or low antral follicle count (<8 antral follicles)
- Fewer than five (5) bipronuclear oocytes
- Day 3 embryo biopsy for any reason
- No minors may enroll
Sites / Locations
- Fertility Center of Las Vegas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional embryo culture
Alternative embryo culture
Arm Description
Conventional embryo culture in dishes, in droplets under oil.
Embryo culture in system using small enclosed containers
Outcomes
Primary Outcome Measures
Blastulation rate
Proportion of cultured embryos that form blastocysts.
Secondary Outcome Measures
Blastocyst morphology
Inner cell mass size, number of trophectoderm cells, blastocyst diameter
IVF outcome
The result of the IVF cycle as no pregnancy, early pregnancy loss, or ongoing pregnancy at 10 weeks gestation (about 7 weeks post-transfer).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02028897
Brief Title
Comparison of Alternative Embryo Culture Systems
Official Title
Comparison of Alternative Embryo Culture Systems
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bruce Shapiro M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes. The other group will be assigned to an enclosed system.
Detailed Description
Qualifying and consenting IVF patients will have approximately half of their developing embryos cultured in droplets covered with oil. The other approximate half of their embryos will be cultured in small enclosed containers. Embryo assignments will be at random. Regardless of culture system, all embryos will be cultured from the bipronuclear stage to the blastocyst stage in the same (Global) media, without the usual refreshing of media on day 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In vitro fertilization, IVF, Embryo culture, Blastocyst transfer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional embryo culture
Arm Type
Active Comparator
Arm Description
Conventional embryo culture in dishes, in droplets under oil.
Arm Title
Alternative embryo culture
Arm Type
Experimental
Arm Description
Embryo culture in system using small enclosed containers
Intervention Type
Other
Intervention Name(s)
Conventional embryo culture
Intervention Type
Other
Intervention Name(s)
Enclosed embryo culture
Primary Outcome Measure Information:
Title
Blastulation rate
Description
Proportion of cultured embryos that form blastocysts.
Time Frame
5 days (sixth day of embryo development)
Secondary Outcome Measure Information:
Title
Blastocyst morphology
Description
Inner cell mass size, number of trophectoderm cells, blastocyst diameter
Time Frame
5 days (sixth day of development)
Title
IVF outcome
Description
The result of the IVF cycle as no pregnancy, early pregnancy loss, or ongoing pregnancy at 10 weeks gestation (about 7 weeks post-transfer).
Time Frame
7 weeks post-transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female age 18 to 40, seeking IVF treatment
Ability to understand English (to obtain informed consent)
Use of an oocyte donor, sperm donor, gestational carrier, and/or genetic testing (with blastocyst biopsy only) are allowed.
Exclusion Criteria:
Diminished ovarian reserve as evidenced by either elevated cycle day 3 follicle stimulating hormone (FSH) level (≥10 IU/L) or low antral follicle count (<8 antral follicles)
Fewer than five (5) bipronuclear oocytes
Day 3 embryo biopsy for any reason
No minors may enroll
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Shapiro, MD, PhD
Organizational Affiliation
Fertility Center of Las Vegas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fertility Center of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Alternative Embryo Culture Systems
We'll reach out to this number within 24 hrs