Sperm Preparation Prior to Intrauterine Insemination Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

This is a randomized controlled trial comparing density gradient centrifugation and microfluidic sperm sorting in patients undergoing intrauterine insemination to evaluate cumulative pregnancy outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing intrauterine insemination

Patient assigned female at birth with age <41

Disqualifiers

Any significant disease or psychiatric disorder that would interfere with the consenting process

Prior intrauterine insemination

Use of frozen donor sperm

Non-English speaker

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zymot Multi sperm separation device

    Device

    Sperm preparation with Zymot Multi sperm preparation device

  • Density gradient centrifugation

    Other intervention

    Sperm preparation with density gradient centrifugation

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Density gradient centrifugationActive comparator 1 intervention
Group B: Zymot sperm separation deviceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative clinical pregnancy rate

The clinical pregnancy rate by treatment group over the course of IUI treatment

Time frame
3 treatment cycles, an average of 5 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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