Recruiting

Sperm Preparation

Sponsor:

UCLA

Code:

NCT05693220

Conditions

Infertility

Infertility Secondary

Infertility Unexplained

Anovulation

Fertility Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zymot Multi sperm separation device

Density gradient centrifugation

Study Details

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.

Conditions

Infertility

Infertility Secondary

Infertility Unexplained

Anovulation

Fertility Disorders

Study ID

NCT05693220

Start date

Feb 5, 2023

Status verified date

Mar, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Density gradient centrifugation

Patients will undergo sperm preparation by density gradient centrifugation

active comparator: Zymot sperm separation device

Patients will undergo sperm preparation by the Zymot sperm separation device

Interventions

Zymot Multi sperm separation device

Sperm preparation with Zymot Multi sperm preparation device

Density gradient centrifugation

Sperm preparation with density gradient centrifugation

Primary outcome measure

  • Cumulative clinical pregnancy rate [ Time Frame: 3 treatment cycles, an average of 5 months ]

Central Contacts and Locations

Central contacts

Alisha T Tolani, MD

6282867307alisha.tolani@ucsf.edu

Elena Hoskin

elena.hoskin@ucsf.edu

Locations

UCSF Center for Reproductive Health

Recruiting

San Francisco, California, United States, 94158

Contacts

Alisha T Tolani, MD

628-286-7307alisha.tolani@ucsf.edu

Elena Hoskin

elena.hoskin@ucsf.edu

Principal Investigator:

Alisha T Tolani, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 3, 2023

Last verified

Mar, 2023

Keywords

  • Intrauterine Insemination
  • Insemination
  • Fertility
  • Infertility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2023-04-03.