Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

NCT ID: NCT02031549

Last Updated: 2015-03-06

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

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-04-30

Brief Summary

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We will investigate potential correlation between SpermComet DNA fragmentation assay results and IVF cycle outcome.

Detailed Description

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A "SpermComet" assay will be used to characterize DNA fragmentation of surplus sperm samples remaining after in vitro fertilization (IVF) cycles. We will investigate potential correlation between these assay results and the outcomes of IVF cycles that used those sperm samples.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SpermComet Assay

All study subjects will have their surplus sperm analyzed for DNA fragmentation with the SpermComet assay.

SpermComet assay

Intervention Type OTHER

Measurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention).

Interventions

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SpermComet assay

Measurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Undergoing IVF
* Surplus sperm available after oocyte insemination
* Consented

Exclusion Criteria

* Surgical sperm extraction
* Use of donated sperm or oocytes
* No minors may participate
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bruce Shapiro M.D.

INDUSTRY

Sponsor Role lead

Responsible Party

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Bruce Shapiro M.D.

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bruce Shapiro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fertility Center of Las Vegas

Locations

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Fertility Center of Las Vegas

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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SAIRB-13-0038

Identifier Type: -

Identifier Source: org_study_id

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