Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

Completed

• Conditions: Infertility
• Interventions: Other: SpermComet assay

• Registration Number: NCT02031549
• Lead Sponsor: Bruce Shapiro M.D.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-09
• Primary Completion: 2014-02
• Study Completion: 2014-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Blastulation rate	6 days	The proportion of oocytes and of fertilized oocytes that form blastocysts.

Secondary Outcome Measures

Name	Time	Method
Embryo grade	6 days	Grade and measurements of blastocysts that form.
Fertilization rate	1 day	Proportion of inseminated oocytes that form exactly two pronuclei.

Trial Locations

Locations (1)

Fertility Center of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States