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Completed

NCT Number: NCT04144621

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

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).

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Key information

Conditions

Blastocyst Implantation Rate

Age range

Up to 37 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ganin Fertility Center

Cairo, 11728, Egypt

About this study

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.

Who can participate

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

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.

Treatment and study plan

ICSI

Procedure

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

Primary outcomes

  1. Blastocyst morphological grading

    Time frame: 5-6 days after ICSI

    Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A to C ( A is the highest quality).

  2. Implantation rate

    Time frame: 6 weeks of pregnancy

    Percentage of the implanted embryos number for each group / number of transferred embryos.

Secondary outcomes

  1. Fertilization rate

    Time frame: 16-19 hours of ICSI

    Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes

  2. Blastulation rate

    Time frame: 5-6 days of ICSI

    Percentage of total blastocysts / total 2PN

  3. Pregnancy rate

    Time frame: After 2 weeks of embryo transfer

    Percentage of pregnant cases / transferred cases for each group ( positive pregnancy test)

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 30, 2019
Registry last updated
Nov 1, 2019

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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