- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02527642
Commercial Single Step (Vitrolife -G-TL™) Media Compared With Cornell Media
Commercial Single Step (Vitrolife -G-TL™) Media Compared With Cornell Media: A Randomized Controlled Trial by Time-Lapse System- Single Step vs Sequential Media
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. The cohort of injected oocytes from each patient will be randomly divided between the one step and sequential medias: CRM (Cornell- Center for Reproductive Medicine) media (C1/C2 or C3) vs G-TL Time Lapse media or G-1/G-2 media. Single step or sequential media are both buffered mediums for culture from oocyte fertilization to blastocyst stage. Sequential media is formulated according to the stages of embryo development and embryos are re-cultured in medias according to their stage of development. Single step (time lapse) media is formulated for continuous culture from D0 to Day 5/6.
Mature oocytes will be randomized via a non-bias computer program into two to four of the study groups: G-TL commercial single step (Vitrolife), Vitrolife's sequential media, Cornell's single step , and Cornell's sequential media. Oocytes will be divided randomly among the various media dependent upon the number of mature oocytes. I.e.: 10 oocytes injected = 2 media groups; 15 oocytes injected = up to 3 media groups; 20 oocytes injected = up to 4 media groups.
"Best grade" embryos will be transferred regardless of media source. If embryos are transferred from multi-source media and if researchers are unable to determine the media source after transfer, the subject will not be included in the outcome data portion of the study- e.g pregnancy outcome.
The Time-Lapse monitoring system will be used as standard clinical practice to observe development and document timing of embryo cleavages and morphology dynamics.
Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART IVF- Assisted Reproductive Technology) treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021
- Center fo Reproductive Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 40 years of age or younger (maternal) 65 years of age or younger (paternal)
- Patient must have 10 or greater than 10 mature oocytes, ICSI only
- Fresh or frozen (including donor) sperm can be used. Fresh oocytes only (including donor)
- Frozen embryos from this study can be included in the outcome portion of this study.
- Single or double Blastocyst transfer only
Exclusion Criteria:
- Patients having PGS (Pre-implantation Genetic Screening)
- 3 or more previous failed cycles
- Sperm obtained by testicular biopsy
- Previous enrollment in the study
- Non blastocyst transfer
- Co-culture patients
- Outcome data portion exclusion only:
Multi-source media transfers if researchers are unable to determine the media source after transfer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CRM sequential media (C1/C2)
CRM sequential media, formulated according to the stages of embryo development, is used to culture the embryos from oocyte fertilization to blastocyst stage.
|
compare media that supports human embryo development in the laboratory (in vitro) using Time-Lapse system.
Other Names:
|
Active Comparator: CRM single step media (C3)
CRM single step media is used to culture the embryos from oocyte fertilization to blastocyst stage.
|
compare media that supports human embryo development in the laboratory (in vitro) using Time-Lapse system.
Other Names:
|
Experimental: Vitrolife media G1/2 Sequential
Vitrolife sequential media, formulated according to the stages of embryo development, is used to culture the embryos from oocyte fertilization to blastocyst stage.
|
compare media that supports human embryo development in the laboratory (in vitro) using Time-Lapse system.
Other Names:
|
Experimental: Vitrolife G-TL Time Lapse media Single Step
G-TL Time Lapse Single step (time lapse) media is formulated for continuous culture from oocyte fertilization to blastocyst stage.
|
compare media that supports human embryo development in the laboratory (in vitro) using Time-Lapse system.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Embryo development
Time Frame: 1 year
|
Comparison of embryo development using standard assessments of morphokenetics of embryo development
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Embryo transfer rate
Time Frame: 1 year
|
Percentage of embryo transferred in each arm.
|
1 year
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Clinical pregnancy rates
Time Frame: within 3 months of embryo transfer
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Percentage of embryos transferred that implant into the uterus by evidence of a fetal sac by ultrasound
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within 3 months of embryo transfer
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants pregnant after Frozen Embryo Transfer
Time Frame: 2 years
|
Pregnancy rate from frozen embryo transfer in each arm.
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2 years
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1411015635
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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