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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02268123

Enrollment

323

Registered

2014-10-20

Start date

2014-10-31

Completion date

2018-07-31

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male Infertility

Keywords

Male Infertility, Sperm DNA Fragmentation, Sperm Abnormality

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

United States

Outcome results