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

Reproductive Medicine Associates of New Jersey

Status: Completed

Conditions: Male Infertility

Study type: Observational

Funder types: Other

Identifiers

NCT02268123

RMA-2014-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 323 patients

Sex: All

Ages: 35 to 40 years old

Volunteers: No Healthy Volunteers

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