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NCT02031549 Clinical Trial

Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

Infertility Clinical Trial

Official title:
Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02031549
Other study ID # SAIRB-13-0038
Secondary ID
Status Completed
Phase N/A
First received January 7, 2014
Last updated March 4, 2015
Start date January 2014
Est. completion date April 2014

Study information
Verified date March 2015
Source Fertility Center of Las Vegas
Contact n/a
Is FDA regulated No
Health authority United States: Schulman Associates IRB
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• SpermComet assay
Measurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention).

Locations
Country Name City State
United States Fertility Center of Las Vegas Las Vegas Nevada

Sponsors (1)
Lead Sponsor Collaborator
Bruce Shapiro M.D.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blastulation rate The proportion of oocytes and of fertilized oocytes that form blastocysts. 6 days No
Secondary Fertilization rate Proportion of inseminated oocytes that form exactly two pronuclei. 1 day No
Secondary Embryo grade Grade and measurements of blastocysts that form. 6 days No
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