Clinical trial NCT02268123: Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation
Official title: Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Infertility
Keywords: Male Infertility
Sperm DNA Fragmentation
Sperm Abnormality
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 323
Sex: ALL
Minimum age (years): 35
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couples completing their first IVF/ICSI cycle at Reproductive Medicine Associates of New Jersey utilizing CCS (Comprehensive Chromosome Screening).

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.

Eligibility criteria: 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

Primary outcomes:
measure: IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation
timeFrame: 28 months
Secondary outcomes:
measure: Relationship between semen analysis parameters and sperm DNA fragmentation
timeFrame: 28 months
measure: Correlation between sperm DNA fragmentation and embryonic aneuploidy
timeFrame: 28 months
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
city: Allentown
country: United States
facility: Reproductive Medicine Associates of Pennsylvania at LeHigh Valley
state: Pennsylvania
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, MD, HCLD
role: PRINCIPAL_INVESTIGATOR
References: