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

Completed

• Conditions: Male Infertility

• Registration Number: NCT02268123
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-20
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation	28 months	rates of fertilization, blastulation, implantation, sustained implantation, delivery and miscarriage

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States

Reproductive Medicine Associates of Pennsylvania at LeHigh Valley; 🇺🇸 Allentown, Pennsylvania, United States