Study Summary
This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.
Eligible Conditions
- Infertility
- Unexplained Infertility
- Anovulation
- Secondary Infertility
- Reproductive Issues
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 3 treatment cycles, an average of 5 months
Month 5
Cumulative clinical pregnancy rate
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Density gradient centrifugation
1 of 2
Zymot sperm separation device
1 of 2
Active Control
270 Total Participants · 2 Treatment Groups
Primary Treatment: Density gradient centrifugation · No Placebo Group · N/A
Density gradient centrifugation
Other
ActiveComparator Group · 1 Intervention: Density gradient centrifugation · Intervention Types: OtherZymot sperm separation device
Device
ActiveComparator Group · 1 Intervention: Zymot Multi sperm separation device · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 treatment cycles, an average of 5 months
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,286 Previous Clinical Trials
11,577,677 Total Patients Enrolled
18 Trials studying Infertility
8,975 Patients Enrolled for Infertility
Mitchell Rosen, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
376 Total Patients Enrolled
3 Trials studying Infertility
374 Patients Enrolled for Infertility
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Those undergoing intrauterine insemination.
You are a female assigned at birth with an age of less than 41.
References
- Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.
- Quinn MM, Jalalian L, Ribeiro S, Ona K, Demirci U, Cedars MI, Rosen MP. Microfluidic sorting selects sperm for clinical use with reduced DNA damage compared to density gradient centrifugation with swim-up in split semen samples. Hum Reprod. 2018 Aug 1;33(8):1388-1393. doi: 10.1093/humrep/dey239.
- 2023. "Sperm Preparation Prior to Intrauterine Insemination Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05693220.
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