Trial Outcomes & Findings for Sperm Selection by Microfluidic Separation Improves Embryo Quality (NCT NCT03085433)
NCT ID: NCT03085433
Last Updated: 2025-12-31
Results Overview
The primary outcome for intent to treat analysis. Day 3 high quality embryo percentage rate will be defined as the percentage of all viable 2PN embryos on day 3 with at least 6 cells and fragmentation/symmetry scores of 1-2. Scale: 1-6 for either fragmentation or symmetry. Lower scores are better. Calculated as ( the number of high-qualify-grade embryos yielded by a participant / the number of all viable 2PN embryos yielded by the participant x 100)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
393 participants
Primary outcome timeframe
3 days following fertilization
Results posted on
2025-12-31
Participant Flow
Enrollment occurred between June 2017 and September 2021. All patients were screened at the time of consultation for eligibility. During this time frame, 1190 patients were eligible to participate and 393 consented to participation.
7 consented participants either voluntarily withdrew from the study or their fertility treatment cycles were cancelled prior to randomization. Ultimately 386 participants were randomized to intervention assignments.
Participant milestones
| Measure |
Microfluidic Sperm Sorting
Couples undergoing in vitro fertilization randomized to microfluidic sperm sorting will have raw semen sorted by the microfluidics chip prior to fertilization with IVF/ICSI.
Microfluidic Sperm Sorting: Microfluidic technology isolates healthy sperm by laminar flow, creating gradients through channels. The microfluidic chip we plan to study in our randomized clinical trial utilizes space-constrained microfluidic sorting to select highly motile and morphologically normal sperm in a flow and chemical-free design. Unlike the standard of density gradient centrifugation, no manipulation of sperm is required in this process. Raw semen is introduced into the inflow and only motile and morphologically normal sperm are able to swim through the chip to the outflow where it is collected for use.
in vitro fertilization: ivf/icsi
|
Conventional Sperm Preparation
Couples undergoing in vitro fertilization randomized to conventional methods for sperm processing will undergo separation of semen by density gradient centrifugation prior to IVF/ICSI.
in vitro fertilization: ivf/icsi
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
194
|
|
Overall Study
COMPLETED
|
157
|
140
|
|
Overall Study
NOT COMPLETED
|
35
|
54
|
Reasons for withdrawal
| Measure |
Microfluidic Sperm Sorting
Couples undergoing in vitro fertilization randomized to microfluidic sperm sorting will have raw semen sorted by the microfluidics chip prior to fertilization with IVF/ICSI.
Microfluidic Sperm Sorting: Microfluidic technology isolates healthy sperm by laminar flow, creating gradients through channels. The microfluidic chip we plan to study in our randomized clinical trial utilizes space-constrained microfluidic sorting to select highly motile and morphologically normal sperm in a flow and chemical-free design. Unlike the standard of density gradient centrifugation, no manipulation of sperm is required in this process. Raw semen is introduced into the inflow and only motile and morphologically normal sperm are able to swim through the chip to the outflow where it is collected for use.
in vitro fertilization: ivf/icsi
|
Conventional Sperm Preparation
Couples undergoing in vitro fertilization randomized to conventional methods for sperm processing will undergo separation of semen by density gradient centrifugation prior to IVF/ICSI.
in vitro fertilization: ivf/icsi
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Physician Decision
|
33
|
50
|
Baseline Characteristics
Sperm Selection by Microfluidic Separation Improves Embryo Quality
Baseline characteristics by cohort
| Measure |
Microfluidic Sperm Sorting
n=157 Participants
Couples undergoing in vitro fertilization randomized to microfluidic sperm sorting will have raw semen sorted by the microfluidics chip prior to fertilization with IVF/ICSI.
Microfluidic Sperm Sorting: Microfluidic technology isolates healthy sperm by laminar flow, creating gradients through channels. The microfluidic chip we plan to study in our randomized clinical trial utilizes space-constrained microfluidic sorting to select highly motile and morphologically normal sperm in a flow and chemical-free design. Unlike the standard of density gradient centrifugation, no manipulation of sperm is required in this process. Raw semen is introduced into the inflow and only motile and morphologically normal sperm are able to swim through the chip to the outflow where it is collected for use.
in vitro fertilization: ivf/icsi
|
Conventional Sperm Preparation
n=140 Participants
Couples undergoing in vitro fertilization randomized to conventional methods for sperm processing will undergo separation of semen by density gradient centrifugation prior to IVF/ICSI.
in vitro fertilization: ivf/icsi
|
Total
n=297 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
157 Participants
n=1000 Participants
|
140 Participants
n=1986 Participants
|
297 Participants
n=2008 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 4.6 • n=1000 Participants
|
38.4 years
STANDARD_DEVIATION 5.7 • n=1986 Participants
|
38.4 years
STANDARD_DEVIATION 5.5 • n=2008 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=1000 Participants
|
140 Participants
n=1986 Participants
|
297 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1000 Participants
|
0 Participants
n=1986 Participants
|
0 Participants
n=2008 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
157 Participants
n=1000 Participants
|
140 Participants
n=1986 Participants
|
297 Participants
n=2008 Participants
|
|
Region of Enrollment
United States
|
157 participants
n=1000 Participants
|
140 participants
n=1986 Participants
|
297 participants
n=2008 Participants
|
PRIMARY outcome
Timeframe: 3 days following fertilizationPopulation: Embryo grade 6c or greater, \<10% fragmentation, symmetry: even/slightly uneven will be considered "high quality".
The primary outcome for intent to treat analysis. Day 3 high quality embryo percentage rate will be defined as the percentage of all viable 2PN embryos on day 3 with at least 6 cells and fragmentation/symmetry scores of 1-2. Scale: 1-6 for either fragmentation or symmetry. Lower scores are better. Calculated as ( the number of high-qualify-grade embryos yielded by a participant / the number of all viable 2PN embryos yielded by the participant x 100)
Outcome measures
| Measure |
Microfluidic Sperm Sorting
n=157 Participants
Couples undergoing in vitro fertilization randomized to microfluidic sperm sorting will have raw semen sorted by the microfluidics chip prior to fertilization with IVF/ICSI.
Microfluidic Sperm Sorting: Microfluidic technology isolates healthy sperm by laminar flow, creating gradients through channels. The microfluidic chip we plan to study in our randomized clinical trial utilizes space-constrained microfluidic sorting to select highly motile and morphologically normal sperm in a flow and chemical-free design. Unlike the standard of density gradient centrifugation, no manipulation of sperm is required in this process. Raw semen is introduced into the inflow and only motile and morphologically normal sperm are able to swim through the chip to the outflow where it is collected for use.
in vitro fertilization: ivf/icsi
|
Conventional Sperm Preparation
n=140 Participants
Couples undergoing in vitro fertilization randomized to conventional methods for sperm processing will undergo separation of semen by density gradient centrifugation prior to IVF/ICSI.
in vitro fertilization: ivf/icsi
|
|---|---|---|
|
Day 3 High Quality Embryo Percentage
|
68 percentage of high quality embryos
Standard Deviation 30.3
|
66 percentage of high quality embryos
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: 1 day following fertilizationNumber of eggs successfully fertilized (2PN embryo count) per number of mature eggs (MII egg count) retrieved per participant. 2PN grade indicates a successfully fertilized embryo. MII grade indicates a metaphase II stage egg which is mature enough to undergo fertilization. (The percentage is calculated for each participant as the number of 2PN embryos obtained / the number of MII eggs obtained x100). The resulting percentages were then averaged to determine the average fertilization rate for participants in each study arm.
Outcome measures
| Measure |
Microfluidic Sperm Sorting
n=157 Participants
Couples undergoing in vitro fertilization randomized to microfluidic sperm sorting will have raw semen sorted by the microfluidics chip prior to fertilization with IVF/ICSI.
Microfluidic Sperm Sorting: Microfluidic technology isolates healthy sperm by laminar flow, creating gradients through channels. The microfluidic chip we plan to study in our randomized clinical trial utilizes space-constrained microfluidic sorting to select highly motile and morphologically normal sperm in a flow and chemical-free design. Unlike the standard of density gradient centrifugation, no manipulation of sperm is required in this process. Raw semen is introduced into the inflow and only motile and morphologically normal sperm are able to swim through the chip to the outflow where it is collected for use.
in vitro fertilization: ivf/icsi
|
Conventional Sperm Preparation
n=140 Participants
Couples undergoing in vitro fertilization randomized to conventional methods for sperm processing will undergo separation of semen by density gradient centrifugation prior to IVF/ICSI.
in vitro fertilization: ivf/icsi
|
|---|---|---|
|
Egg Fertilization Rate
|
75.2 percentage of eggs that fertilized
Standard Deviation 17.8
|
79.4 percentage of eggs that fertilized
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: 14 days following embryo transferPregnancy rate will be defined as achieving a clinical pregnancy ( an ultrasound demonstrating gestational sac with yolk sac) per embryo transfer procedure attempt.
Outcome measures
| Measure |
Microfluidic Sperm Sorting
n=157 Participants
Couples undergoing in vitro fertilization randomized to microfluidic sperm sorting will have raw semen sorted by the microfluidics chip prior to fertilization with IVF/ICSI.
Microfluidic Sperm Sorting: Microfluidic technology isolates healthy sperm by laminar flow, creating gradients through channels. The microfluidic chip we plan to study in our randomized clinical trial utilizes space-constrained microfluidic sorting to select highly motile and morphologically normal sperm in a flow and chemical-free design. Unlike the standard of density gradient centrifugation, no manipulation of sperm is required in this process. Raw semen is introduced into the inflow and only motile and morphologically normal sperm are able to swim through the chip to the outflow where it is collected for use.
in vitro fertilization: ivf/icsi
|
Conventional Sperm Preparation
n=140 Participants
Couples undergoing in vitro fertilization randomized to conventional methods for sperm processing will undergo separation of semen by density gradient centrifugation prior to IVF/ICSI.
in vitro fertilization: ivf/icsi
|
|---|---|---|
|
Pregnancy Rate
|
82 Participants
|
78 Participants
|
Adverse Events
Microfluidic Sperm Sorting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Sperm Preparation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place