Sperm Preparation Prior to Intrauterine Insemination Study
- Conditions
- AnovulationFertility DisordersReproductive IssuesInfertility SecondaryInfertility UnexplainedInfertility
- Registration Number
- NCT05693220
- Lead Sponsor
- University of California, San Francisco
- Brief 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.
- Detailed Description
Study participants will be randomized to either standard sperm preparation (density gradient centrifugation) versus sperm preparation with the Zymot Multi sperm preparation device for their three month intrauterine insemination treatment course. Patients will follow standard treatment plans designed by their fertility physician and will be followed until referred for prenatal care at 8-10 weeks of pregnancy to determine pregnancy outcomes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 270
- Patients undergoing intrauterine insemination
- Patient assigned female at birth with age <41
- Any significant disease or psychiatric disorder that would interfere with the consenting process
- Prior intrauterine insemination
- Use of frozen donor sperm
- Non-English speaker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cumulative clinical pregnancy rate 3 treatment cycles, an average of 5 months The clinical pregnancy rate by treatment group over the course of IUI treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCSF Center for Reproductive Health
🇺🇸San Francisco, California, United States
UCSF Center for Reproductive Health🇺🇸San Francisco, California, United StatesAlisha T Tolani, MDPrincipal InvestigatorElena HoskinContactelena.hoskin@ucsf.eduMitchell Rosen, MDPrincipal Investigator