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OpenTrials
Completed

NCT Number: NCT02031549

Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SpermComet assay

Other

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

Primary outcomes

  1. Blastulation rate

    Time frame: 6 days

    The proportion of oocytes and of fertilized oocytes that form blastocysts.

Secondary outcomes

  1. Fertilization rate

    Time frame: 1 day

    Proportion of inseminated oocytes that form exactly two pronuclei.

  2. Embryo grade

    Time frame: 6 days

    Grade and measurements of blastocysts that form.

Sponsors and collaborators

Lead sponsor

Bruce Shapiro M.D.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2014
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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