Sperm Preparation Prior to Intrauterine Insemination Study

NCT ID: NCT05693220

Last Updated: 2023-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-05

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Infertility Infertility Secondary Infertility Unexplained Anovulation Fertility Disorders Reproductive Issues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Density gradient centrifugation

Patients will undergo sperm preparation by density gradient centrifugation

Group Type ACTIVE_COMPARATOR

Density gradient centrifugation

Intervention Type OTHER

Sperm preparation with density gradient centrifugation

Zymot sperm separation device

Patients will undergo sperm preparation by the Zymot sperm separation device

Group Type ACTIVE_COMPARATOR

Zymot Multi sperm separation device

Intervention Type DEVICE

Sperm preparation with Zymot Multi sperm preparation device

Interventions

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Zymot Multi sperm separation device

Sperm preparation with Zymot Multi sperm preparation device

Intervention Type DEVICE

Density gradient centrifugation

Sperm preparation with density gradient centrifugation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mitchell Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF Center for Reproductive Health

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alisha T Tolani, MD

Role: CONTACT

6282867307

Elena Hoskin

Role: CONTACT

Facility Contacts

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Alisha T Tolani, MD

Role: primary

628-286-7307

Elena Hoskin

Role: backup

References

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Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.

Reference Type BACKGROUND
PMID: 31543253 (View on PubMed)

Quinn MM, Jalalian L, Ribeiro S, Ona K, Demirci U, Cedars MI, Rosen MP. Microfluidic sorting selects sperm for clinical use with reduced DNA damage compared to density gradient centrifugation with swim-up in split semen samples. Hum Reprod. 2018 Aug 1;33(8):1388-1393. doi: 10.1093/humrep/dey239.

Reference Type BACKGROUND
PMID: 30007319 (View on PubMed)

Other Identifiers

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22-36913

Identifier Type: -

Identifier Source: org_study_id

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