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

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268123
• Other study ID #: RMA-2014-05
• Status: Completed
• Start date: October 2014
• Est. completion date: July 2018

Study information

• Verified date: September 2018
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of Pennsylvania at LeHigh Valley	Allentown	Pennsylvania
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation	rates of fertilization, blastulation, implantation, sustained implantation, delivery and miscarriage	28 months
Secondary	Relationship between semen analysis parameters and sperm DNA fragmentation	Semen analysis parameters (total motile sperm count, Volume, Concentration, Grade 1-4 )	28 months
Secondary	Correlation between sperm DNA fragmentation and embryonic aneuploidy		28 months