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

Completed

• Conditions: Implantation Rate; Blastocyst
• Interventions: Procedure: ICSI

• Registration Number: NCT04144621
• Lead Sponsor: Ganin Fertility Center

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-30
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abnormal SDF	ICSI	Couples with male partners having SDF greater than 20% using TUNEL assay
Normal SDF	ICSI	Couples with male partners having SDF lower than 20% using TUNEL assay

Primary Outcome Measures

Name	Time	Method
Blastocyst morphological grading	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).
Implantation rate	6 weeks of pregnancy	Percentage of the implanted embryos number for each group / number of transferred embryos.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ganin Fertility Center; 🇪🇬 Cairo, Egypt