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Sperm DNA Fragmentation Effects on Blastocyst Morphology Grading, Pregnancy Rate and Implantation Rate

The Correlation of Sperm DNA Fragmentation With Blastocyst Grading and Its Implantation Potential

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04144621
Enrollment
189
Registered
2019-10-30
Start date
2018-01-01
Completion date
2019-04-01
Last updated
2019-11-01

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

Conditions

Blastocyst, Implantation Rate

Keywords

Sperm DNA fragmentation, Implantation rate, Pregnancy rate, Blastocyst grading

Brief summary

Retrospective cohort study for 189 couples assigned to normal and abnormal Sperm DNA fragmentation (SDF) groups.To determine the effect of SDF on blastocyst's trophectoderm (TE), Inner cell mass (ICM) morphology grading, and implantation rate. Semen in both groups was processed by density gradient (DG).

Detailed description

Purpose: to determine if sperm DNA fragmentation (SDF) has a correlation with Blastocyst's trophectoderm (TE) and Inner cell mass (ICM) grading, or with the implantation rate? Method: Retrospective cohort study for 189 couples, assigned to normal SDF group (121 cases), and abnormal SDF group (68 cases). Semen in both groups was processed by double layer density gradient (DG). Statistical analysis done using SPSS version 22.

Interventions

PROCEDUREICSI

Intracytoplasmic sperm injection of female partner oocytes with ejaculated sperm selected by density gradient centrifugation

Sponsors

Ganin Fertility Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 37 Years

Inclusion criteria

* All cases in this study have to reach the blastocyst stage. * Female age ≤37 years old. * Male sperm count ≥ 5 million.

Exclusion criteria

* Usage of sperm selection techniques. * Testicular aspiration or testicular biopsies. * Oocyte or sperm donation.

Design outcomes

Primary

MeasureTime frameDescription
Blastocyst morphological grading5-6 days after ICSIMorphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A to C ( A is the highest quality).
Implantation rate6 weeks of pregnancyPercentage of the implanted embryos number for each group / number of transferred embryos.

Secondary

MeasureTime frameDescription
Fertilization rate16-19 hours of ICSIPercentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
Blastulation rate5-6 days of ICSIPercentage of total blastocysts / total 2PN
Pregnancy rateAfter 2 weeks of embryo transferPercentage of pregnant cases / transferred cases for each group ( positive pregnancy test)

Countries

Egypt

Outcome results

None listed

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