Sperm Selection by Microfluidic Separation Improves Embryo Quality
NCT ID: NCT03085433
Last Updated: 2025-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
393 participants
INTERVENTIONAL
2017-06-20
2022-04-30
Brief Summary
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Detailed Description
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In contrast, microfluidic-based sperm sorting has the capability of selectively isolating highly motile, morphologically normal sperm with high DNA integrity from an unprocessed semen sample. 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 semen samples from healthy male volunteers split into standard processing via centrifugation and swim-up procedure compared with microfluidic sperm sorting, a significantly higher percent motility and lower rate of sperm DNA fragmentation was detected with microfluidic sperm sampling. The microfluidic sperm sorting technique has thus proven to be an efficient and reliable means of sperm preparation compared with the centrifugation and swim-up procedure. While this microfluidic chip has been used clinically in Mexico, Turkey, South Africa, Italy, Greece, and Switzerland resulting in over 5,000 live births, its use in clinical practice has not been rigorously studied. We aim to compare traditional preparation and microfluidic sperm sorting on assisted reproductive technology outcomes including oocyte fertilization and embryo quality in subjects with a history of poor embryo quality electing to undergo a repeat in vitro fertilization cycle for infertility.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with and without a history of prior IVF cycles will be included.
* All eligible couples where both partners are \>=18 years of age will be asked to join the study.
Exclusion Criteria
* Female partner with anovulation (PCOS, FHA)
* Female partner age \>41
* Female partner AFC\< 7
* Female partner with obstructed fallopian tubes (assessed in all patients prior to IVF)
* Use of oocyte donor
* Either Partner:
* Cancer diagnosis in either partner
* Any significant disease or psychiatric disorder that would interfere with consenting process
* Treatment History:
o History of \>1 prior cycle cancellation due to poor response
* Treatment Plan:
* Embryo co-culture
* Use of adjunctive non-gonadotropin medications to improve embryo quality: growth hormone, sildenafil
18 Years
65 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Mitchell Rosen, M.D
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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References
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Quinn MM, Ribeiro S, Juarez-Hernandez F, Simbulan RK, Jalalian L, Cedars MI, Rosen MP. Microfluidic preparation of spermatozoa for ICSI produces similar embryo quality to density-gradient centrifugation: a pragmatic, randomized controlled trial. Hum Reprod. 2022 Jun 30;37(7):1406-1413. doi: 10.1093/humrep/deac099.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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16-21273
Identifier Type: -
Identifier Source: org_study_id