Sperm Preparation Techniques for Infertility
(PIoUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two ways of preparing sperm for fertility treatment. One method spins the sperm to pick out the good ones, while the other uses a special device to sort them naturally. The study aims to see which method leads to better pregnancy outcomes for patients undergoing intrauterine insemination.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is sperm preparation using techniques like density gradient centrifugation and ZyMōt devices safe for humans?
The available research suggests that sperm preparation techniques like density gradient centrifugation and ZyMōt devices are generally safe for use in humans, as they are commonly used in assisted reproductive technologies like in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) without reported safety concerns.12345
How does the treatment using Density Gradient Centrifugation and ZyMōt Multi Sperm Separation Device differ from other infertility treatments?
The Density Gradient Centrifugation and ZyMōt Multi Sperm Separation Device are unique because they focus on selecting the best quality sperm by separating them based on their density and motility, which can improve the chances of successful fertilization. Unlike some other methods, the ZyMōt device uses microfluidic technology to gently select sperm without the stress of centrifugation, potentially preserving sperm quality better.24678
What data supports the effectiveness of the treatment Density gradient centrifugation, Density Gradient Centrifugation, Isopycnic Centrifugation, Rate-Zonal Centrifugation, Zymot Multi sperm separation device, ZyMōt Multi Sperm Separation Device, ZyMōt ICSI Sperm Separation Device for infertility?
Research shows that density gradient centrifugation can improve sperm quality by increasing motility and reducing damage, which is important for successful fertilization. Additionally, the ZyMot Multi device has been shown to improve clinical pregnancy rates in IVF by selecting sperm with better DNA integrity.12469
Who Is on the Research Team?
Mitchell Rosen, M.D.
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for individuals assigned female at birth, under the age of 41, who are undergoing intrauterine insemination due to anovulation or unexplained infertility. It's not suitable for those with significant diseases or psychiatric disorders that affect consent, users of frozen donor sperm, non-English speakers, or those with prior intrauterine inseminations.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo intrauterine insemination treatment with either density gradient centrifugation or Zymot sperm separation device over three cycles
Follow-up
Participants are monitored for pregnancy outcomes until referred for prenatal care at 8-10 weeks of pregnancy
What Are the Treatments Tested in This Trial?
Interventions
- Density gradient centrifugation
- Zymot Multi sperm separation device
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor