Comparison of Alternative Embryo Culture Systems

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Alternative Embryo Culture Systems

Conditions
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Infertility

Intervention / Treatment
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* Other: Conventional embryo culture
* Other: Enclosed embryo culture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional embryo culture<br>Conventional embryo culture in dishes, in droplets under oil. | Other: Conventional embryo culture<br> <br> |
| Experimental: Alternative embryo culture<br>Embryo culture in system using small enclosed containers | Other: Enclosed embryo culture<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastulation rate | Proportion of cultured embryos that form blastocysts. | 5 days (sixth day of embryo development) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst morphology | Inner cell mass size, number of trophectoderm cells, blastocyst diameter | 5 days (sixth day of development) | 
| 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). | 7 weeks post-transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In vitro fertilization, IVF, Embryo culture, Blastocyst transfer