Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation

Study Overview
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Brief Summary
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The purpose of this study is to determine if sperm DNA fragmentation is associated with in vitro fertilization (IVF) outcomes when euploid embryos are transferred.

Detailed Description
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The purpose of this study is to determine if sperm DNA fragmentation is associated with in vitro fertilization (IVF) outcomes when euploid embryos are transferred. Euploid embryos are those that have a complete set of chromosomes (46, XX or 46, XY). Sperm DNA fragmentation refers to sperm DNA that is damaged or has an altered structure. The sperm chromatin structure assay (SCSA) is a method to evaluate sperm DNA Fragmentation. Couples will undergo a routine IVF cycle at Reproductive Medicine Associates of New Jersey. Semen specimens collected on the day of ICSI will undergo semen analysis as per routine. An aliquot of semen (0.5- 1mL) will be collected for subsequent evaluation of DNA fragmentation by the Sperm Chromatin Structure Assay (SCSA) testing at SCSA Diagnostics. All embryo biopsies will undergo CCS analysis in the genomics laboratory, Foundation for Assessment and Enhancement of Embryonic Competence.

Official Title
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Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation

Conditions
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Male Infertility

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completing first IVF/ICSI cycle at Reproductive Medicine Associates of New Jersey Couple undergoing CCS (Comprehensive Chromosome Screening) Female age 35-40 years Male will have to refrain from ejaculation no less than 2 days but no greater than 5 days prior semen specimen production on day of oocyte retrieval Exclusion Criteria: Known genetic abnormality Use of sperm donation or cryopreserved sperm Use of Oocyte donation Use of gestational carrier Use of testicular aspiration or biopsy procedures to obtain sperm Presence of varicosele Presence of hydrosalpinges that communicate with endometrial cavity Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation | rates of fertilization, blastulation, implantation, sustained implantation, delivery and miscarriage | 28 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between semen analysis parameters and sperm DNA fragmentation | Semen analysis parameters (total motile sperm count, Volume, Concentration, Grade 1-4 ) | 28 months | 
| Correlation between sperm DNA fragmentation and embryonic aneuploidy |  | 28 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Infertility, Sperm DNA Fragmentation, Sperm Abnormality