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

October 30, 2019 updated by: Ganin Fertility Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11728
        • Ganin Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICSI patients in Ganin Fertility Center from January 2018 to September 2018.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal SDF
Couples with male partners having SDF lower than 20% using TUNEL assay
Procedure: ICSI
Intracytoplasmic sperm injection of female partner oocytes with ejaculated sperm selected by density gradient centrifugation
Abnormal SDF
Couples with male partners having SDF greater than 20% using TUNEL assay
Procedure: ICSI
Intracytoplasmic sperm injection of female partner oocytes with ejaculated sperm selected by density gradient centrifugation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5-6 days after ICSI
Implantation rate
Time Frame: 6 weeks of pregnancy
Percentage of the implanted embryos number for each group / number of transferred embryos.
6 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: 16-19 hours of ICSI
Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
16-19 hours of ICSI
Blastulation rate
Time Frame: 5-6 days of ICSI
Percentage of total blastocysts / total 2PN
5-6 days of ICSI
Pregnancy rate
Time Frame: After 2 weeks of embryo transfer
Percentage of pregnant cases / transferred cases for each group ( positive pregnancy test)
After 2 weeks of embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ganin Fertility Center

Investigators

  • Principal Investigator: Eman Hassanen, BSc, Ganin Fertility Center
  • Principal Investigator: Manar Hozyen, MSc, Ganin Fertility Center
  • Study Chair: Hosam Zaki, MSc, FRCOG, Ganin Fertility Center
  • Principal Investigator: Hanaa El Khedr, Ganin Fertility Center
  • Principal Investigator: Yasmine Azzouz, BSc, Ganin Fertility Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MH0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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