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Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

Prospective Observational Correlation of Sperm Assay Results With Blastocyst Formation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02031549
Enrollment
40
Registered
2014-01-09
Start date
2014-01-31
Completion date
2014-04-30
Last updated
2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

OTHERSpermComet assay

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

Sponsors

Bruce Shapiro M.D.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blastulation rate6 daysThe proportion of oocytes and of fertilized oocytes that form blastocysts.

Secondary

MeasureTime frameDescription
Fertilization rate1 dayProportion of inseminated oocytes that form exactly two pronuclei.
Embryo grade6 daysGrade and measurements of blastocysts that form.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026