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

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.

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

35 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Reproductive Medicine Associates of New Jersey, Basking Ridge, New Jersey, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation

Time frame: 28 months

rates of fertilization, blastulation, implantation, sustained implantation, delivery and miscarriage

Secondary outcomes

Relationship between semen analysis parameters and sperm DNA fragmentation

Time frame: 28 months

Semen analysis parameters (total motile sperm count, Volume, Concentration, Grade 1-4 )
Correlation between sperm DNA fragmentation and embryonic aneuploidy

Time frame: 28 months

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Oct 20, 2014
Registry last updated: Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed