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GM508 CultActive is a bicarbonate buffered reagent and ready-to-use designed to investigate oocytes of patients with failed fertilization after previous Intracytoplasmatic Sperm Injection cycles. The investigators hypothesize that GM508 CultActive will improve the fertilization rate and embryo development of such IVF patients (a history of poor fertilization, a history of poor embryo quality, and over 40 years old expected challenging to conceive).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oocytes treated with calcium ionophore | Experimental | Oocytes treated with a ready-to-use ionophore compound (GM508 CultActive, Gynemed) within 15 min after ICSI (or 18 min in IVF). After 15 min of incubation in GM508 CultActive and a thorough washing process, the oocytes subjected to AOA will transfer to the same time-lapse culture dish with the controlled sibling group. |
|
| oocytes undergo routine IVF/ICSI protocol | No Intervention | Untreated control oocytes will immediately place into the time-lapse imaging system, and the culture protocol was routine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcium ionophore | Other | The intervention group will be treated with a ready-to-use ionophore medium (GM508 CultActive, Gynemed) within 15 min after ICSI (or 18 min in IVF) based on the situation of sperm. After 15 min of incubation in GM508 CultActive and a thorough washing process, the oocytes will be cultured in the same protocol as the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| fertilization rate | The normal fertilization rate will defined as the number of zygotes with 2PN and 2PB per the total number of mature oocytes | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| blastocyst formation rate | NO. of blastocysts per 2PN zygotes | Day 5 |
| top-quality blastocyst formation rate | No. of 3AA, 4AA, 5AA or 6AA blastocysts / 2PN zygotes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Kaohsiung City | 123 | Taiwan |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| C565840 | Long Qt Syndrome 3 |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D061207 | Calcium Ionophores |
| ID | Term |
|---|---|
| D007476 | Ionophores |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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|
| Day 5 |
| pregnancy outcome | pregnancy rates, abortion rate, live birth rates,congenital anomaly rate | 1 year |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |