Anovulation, Fertility Disorders, Infertility, Infertility Secondary, Infertility Unexplained, Reproductive Issues
Conditions
Keywords
Intrauterine Insemination, Insemination, Fertility, Infertility
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.
Interventions
DEVICEZymot Multi sperm separation device
Sperm preparation with Zymot Multi sperm preparation device
Sperm preparation with density gradient centrifugation
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing intrauterine insemination * Patient assigned female at birth with age \<41
Exclusion criteria
* Any significant disease or psychiatric disorder that would interfere with the consenting process * Prior intrauterine insemination * Use of frozen donor sperm * Non-English speaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTAlisha T Tolani, MD
CONTACTElena Hoskin
PRINCIPAL_INVESTIGATORMitchell Rosen, MD
University of California, San Francisco
Outcome results
None listed