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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Blastocyst, Implantation Rate

Intervention / Treatment
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* Procedure: ICSI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 37 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sperm DNA fragmentation, Implantation rate, Pregnancy rate, Blastocyst grading