Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation
1 other identifier
observational
323
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
October 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedSeptember 11, 2018
September 1, 2018
3.8 years
October 10, 2014
September 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Relationship between semen analysis parameters and sperm DNA fragmentation
28 months
Correlation between sperm DNA fragmentation and embryonic aneuploidy
28 months
Eligibility Criteria
Couples completing their first IVF/ICSI cycle at Reproductive Medicine Associates of New Jersey utilizing CCS (Comprehensive Chromosome Screening).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920, United States
Reproductive Medicine Associates of Pennsylvania at LeHigh Valley
Allentown, Pennsylvania, 18104, United States
Biospecimen
An aliquot semen (0.5 - 1mL) will be collected and cryopreserved for analysis for DNA Fragmentation. Two tubes of serum (approximately 20 mL) will be collected from male partner via venipuncture.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard T Scott, MD, HCLD
Reproductive Medicine Associates of New Jersey
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2014
First Posted
October 20, 2014
Study Start
October 1, 2014
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
September 11, 2018
Record last verified: 2018-09