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Test culture, Control culture · 1 trial · 1 indication
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 7 in percentage of number of embryo transferred.
| Arm | Type | Description |
|---|---|---|
| Test culture | EXPERIMENTAL | Culture with GM-CSF |
| Control culture | PLACEBO_COMPARATOR | Culture without GM-CSF |
| Name | Type | Description |
|---|---|---|
| Test culture | DEVICE | A standard culture medium with added GM-CSF (ready-to-use) |
| Control culture | DEVICE | The same standard culture medium, but without any additions (ready-to-use) |
Inclusion Criteria: * The couple or single woman has signed an informed consent form before any trial-related activities. * In Vitro Fertilization (IVF) or IntraCytoplasmic Sperm Injection (ICSI) treatment indicated * 25-39 years of age (both inclusive) * Regular menstrual cycle: 21-35 days (both i...
Test culture, Control culture is an investigational therapy being studied for infertility. It is being evaluated in a Phase 3 clinical trial for use in human in vitro fertilization (IVF). The study enrolled 1,332 female participants aged 25 years and older in Denmark and Sweden.
Test culture, Control culture is being developed by The Cooper Companies, Inc., which trades under the ticker symbol COO. The company is conducting clinical research on this product for infertility treatment in the context of IVF procedures.
Test culture, Control culture is in Phase 3 clinical development. The Phase 3 trial, identified as NCT00565747, has been completed. The study was a randomized, double-blind, placebo-controlled trial with biomarker selection, enrolling 1,332 participants.
Test culture, Control culture has one completed Phase 3 clinical trial, NCT00565747, titled 'Efficacy Study of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) for Use in Human IVF.' The trial enrolled 1,332 female participants with infertility and was conducted in Denmark and Sweden.
Test culture, Control culture is associated with granulocyte-macrophage colony stimulating factor (GM-CSF) in the context of the clinical trial. The Phase 3 study NCT00565747 evaluates GM-CSF for use in human IVF, and Test culture, Control culture refers to the test and control culture conditions in that study.