Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 1:26 AM
Ignite Modification Date: 2025-12-25 @ 11:36 PM
NCT ID: NCT04818593
Description: PI monitored for adverse events/serious adverse events/all-cause mortality. The number of participants at Risk (n = 33) represents the number of dyads assigned to each intervention for whom adverse event/serious adverse event/all-cause mortality data were collected.
Frequency Threshold: 0
Time Frame: Up to 2 weeks post-embryo transfer
Study: NCT04818593
Study Brief: A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ZyMot Separation Treatment ZyMot Multi Sperm Separation Device (850 ul): 850 uL of untreated semen will be directly deposited into the inlet port of the ZyMotTM Multi device, followed by placement of 750 uL culture medium in the outlet port and throughout the upper collection chamber. The device will then be incubated in a humidified 37C CO2 incubator for 30 minutes. During incubation, the healthiest and most motile sperm will swim through the microporous filter and into the upper collection chamber, where they will be recovered via the outlet port. 500 uL of the sperm sample will be removed and placed in a separate tube for analysis and insemination. 0 None 0 33 0 33 View
Density Gradient Centrifugation Control Density Gradient Centrifugation: Density gradient centrifugation will be performed using a one-layer preparation of 90% Isolate in 15 mL conical tubes. Semen will be layered over 1 mL of gradient and then centrifuged for 15 min at 300xg. The supernatant will be removed and discarded. The sperm pellet will be washed by mixing with Multipurpose Handling Medium Complete and centrifuging the sample for 5 min at 400xg. After the wash, the supernatant is removed and discarded and the pellet is re-suspended in culture medium, assessed for sperm parameters, and held at room temperature until insemination. 0 None 0 33 0 33 View
Serious Events(If Any):
Other Events(If Any):