Male InfertilityNCT02268123
Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation
An observational study of Male Infertility, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 40 years
- Conditions the study is for
- Male Infertility
- How many people
- 323 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2014to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Couples completing their first IVF/ICSI cycle at Reproductive Medicine Associates of New Jersey utilizing CCS (Comprehensive Chromosome Screening).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Reproductive Medicine Associates of Pennsylvania at LeHigh Valley
Allentown, Pennsylvania, 18104
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
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.
Read the 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.
- Conditions
- Male Infertility
- Keywords
- Male Infertility, Sperm DNA Fragmentation, Sperm Abnormality
- Medical subject headings
- Infertility, Male
What is being measured
The primary outcome is the main question the study is designed to answer.
IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation
rates of fertilization, blastulation, implantation, sustained implantation, delivery and miscarriage
Measured: 28 months
Secondary outcomes (2)
Relationship between semen analysis parameters and sperm DNA fragmentation
Semen analysis parameters (total motile sperm count, Volume, Concentration, Grade 1-4 )
Measured: 28 months
Correlation between sperm DNA fragmentation and embryonic aneuploidy
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, MD, HCLD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268123
- Sponsor's protocol ID
- RMA-2014-05
- Status last verified
- Sep 2018
- First submitted
- 10 Oct 2014
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation
- ClinicalTrials.gov ID
- NCT02268123
- Acronym / sponsor ID
- RMA-2014-05
- Conditions
- Male Infertility
- Keywords
- Male Infertility, Sperm DNA Fragmentation, Sperm Abnormality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Couples completing their first IVF/ICSI cycle at Reproductive Medicine Associates of New Jersey utilizing CCS (Comprehensive Chromosome Screening).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Relationship between semen analysis parameters and sperm DNA fragmentation
Time frame: 28 months
Correlation between sperm DNA fragmentation and embryonic aneuploidy
Time frame: 28 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Scott, MD, HCLD principal investigator
Reproductive Medicine Associates of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IVF/ICSI Pregnancy Outcomes with euploid blastocyst transfer based on sperm DNA fragmentation (time frame: 28 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.