Male InfertilityTBA on IVFNCT01232465
Impact of Sperm DNA Integrity on In Vitro Cycles
An observational study of Male Infertility and Unexplained Infertility, run by Northwell Health at 1 site in United States.
Trial summary
Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any, between IVF success and sperm DNA integrity. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Male Infertility, Unexplained Infertility, Abortion, Habitual
- Type of treatment
- Injection or infusion
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: couples undergoing IVF treatement at the Center for Human Reproduction, North Shore University Hospital, Manhasset NY
Who may be able to join
- couple undergoing IVF at the Center for Human Reproduction
- sperm sample given from partner (not a donor)
Who cannot join
- low sperm concentration (<5 million/cc)
- using a donor sample
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Human Reproduction
Manhasset, New York, 11303
About this study
Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any, between IVF success and sperm DNA integrity.
- Keywords
- sperm DNA integrity, Toluidine blue assay (TBA), IVF outcome
- Medical subject headings
- Infertility, Male, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IVF | those individuals undergoing conventional IVF to inseminate their retrieved eggs | |
| ICSI | those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avner E Hershlag, MD, Principal investigator, Center for Human Reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232465
- Sponsor's protocol ID
- 10-249A
- Acronym
- TBA on IVF
- Status last verified
- Mar 2014
- First submitted
- 28 Oct 2010
- Last updated
- 11 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Andreetta AM, Stockert JC, Barrera C. A simple method to detect sperm chromatin abnormalities: cytochemical mechanism and possible value in predicting semen quality in assisted reproductive procedures. Int J Androl. 1995 Jun;18 Suppl 1:23-8. doi: 10.1111/j.1365-2605.1995.tb00634.x.
PubMed 7558384Erenpreisa J, Erenpreiss J, Freivalds T, Slaidina M, Krampe R, Butikova J, Ivanov A, Pjanova D. Toluidine blue test for sperm DNA integrity and elaboration of image cytometry algorithm. Cytometry A. 2003 Mar;52(1):19-27. doi: 10.1002/cyto.a.10015.
PubMed 12596248Erenpreiss J, Bars J, Lipatnikova V, Erenpreisa J, Zalkalns J. Comparative study of cytochemical tests for sperm chromatin integrity. J Androl. 2001 Jan-Feb;22(1):45-53.
PubMed 11191087Erenpreiss J, Jepson K, Giwercman A, Tsarev I, Erenpreisa J, Spano M. Toluidine blue cytometry test for sperm DNA conformation: comparison with the flow cytometric sperm chromatin structure and TUNEL assays. Hum Reprod. 2004 Oct;19(10):2277-82. doi: 10.1093/humrep/deh417. Epub 2004 Jul 22.
PubMed 15271869Schlegel PN, Paduch DA. Yet another test of sperm chromatin structure. Fertil Steril. 2005 Oct;84(4):854-9. doi: 10.1016/j.fertnstert.2005.04.050.
PubMed 16213834Collins JA, Barnhart KT, Schlegel PN. Do sperm DNA integrity tests predict pregnancy with in vitro fertilization? Fertil Steril. 2008 Apr;89(4):823-31. doi: 10.1016/j.fertnstert.2007.04.055. Epub 2007 Jul 20.
PubMed 17644094Simon L, Brunborg G, Stevenson M, Lutton D, McManus J, Lewis SE. Clinical significance of sperm DNA damage in assisted reproduction outcome. Hum Reprod. 2010 Jul;25(7):1594-608. doi: 10.1093/humrep/deq103. Epub 2010 May 6.
PubMed 20447937Tarozzi N, Bizzaro D, Flamigni C, Borini A. Clinical relevance of sperm DNA damage in assisted reproduction. Reprod Biomed Online. 2007 Jun;14(6):746-57. doi: 10.1016/s1472-6483(10)60678-5.
PubMed 17579991Zini A, Libman J. Sperm DNA damage: clinical significance in the era of assisted reproduction. CMAJ. 2006 Aug 29;175(5):495-500. doi: 10.1503/cmaj.060218.
PubMed 16940270Sharma RK, Said T, Agarwal A. Sperm DNA damage and its clinical relevance in assessing reproductive outcome. Asian J Androl. 2004 Jun;6(2):139-48.
PubMed 15154089Speyer BE, Pizzey AR, Ranieri M, Joshi R, Delhanty JD, Serhal P. Fall in implantation rates following ICSI with sperm with high DNA fragmentation. Hum Reprod. 2010 Jul;25(7):1609-18. doi: 10.1093/humrep/deq116. Epub 2010 May 22.
PubMed 20495207Tsarev I, Bungum M, Giwercman A, Erenpreisa J, Ebessen T, Ernst E, Erenpreiss J. Evaluation of male fertility potential by Toluidine Blue test for sperm chromatin structure assessment. Hum Reprod. 2009 Jul;24(7):1569-74. doi: 10.1093/humrep/dep068. Epub 2009 Mar 21.
PubMed 19304993
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sperm DNA Integrity on In Vitro Cycles
- ClinicalTrials.gov ID
- NCT01232465
- Acronym / sponsor ID
- TBA on IVF / 10-249A
- Keywords
- sperm DNA integrity, Toluidine blue assay (TBA), IVF outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any, between IVF success and sperm DNA integrity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVF | – | –those individuals undergoing conventional IVF to inseminate their retrieved eggs |
| ICSI | – | –those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- couples undergoing IVF treatement at the Center for Human Reproduction, North Shore University Hospital, Manhasset NY
Key inclusion criteria (2 listed)
- couple undergoing IVF at the Center for Human Reproduction
- sperm sample given from partner (not a donor)
Key exclusion criteria (2 listed)
- low sperm concentration (<5 million/cc)
- using a donor sample
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
Pregnancy
Time frame: 9 months
detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7558384Andreetta AM, Stockert JC, Barrera C. A simple method to detect sperm chromatin abnormalities: cytochemical mechanism and possible value in predicting semen quality in assisted reproductive procedures. Int J Androl. 1995 Jun;18 Suppl 1:23-8. doi: 10.1111/j.1365-2605.1995.tb00634.x.
- Background: PubMed 12596248Erenpreisa J, Erenpreiss J, Freivalds T, Slaidina M, Krampe R, Butikova J, Ivanov A, Pjanova D. Toluidine blue test for sperm DNA integrity and elaboration of image cytometry algorithm. Cytometry A. 2003 Mar;52(1):19-27. doi: 10.1002/cyto.a.10015.
- Background: PubMed 11191087Erenpreiss J, Bars J, Lipatnikova V, Erenpreisa J, Zalkalns J. Comparative study of cytochemical tests for sperm chromatin integrity. J Androl. 2001 Jan-Feb;22(1):45-53.
- Background: PubMed 15271869Erenpreiss J, Jepson K, Giwercman A, Tsarev I, Erenpreisa J, Spano M. Toluidine blue cytometry test for sperm DNA conformation: comparison with the flow cytometric sperm chromatin structure and TUNEL assays. Hum Reprod. 2004 Oct;19(10):2277-82. doi: 10.1093/humrep/deh417. Epub 2004 Jul 22.
- Background: PubMed 16213834Schlegel PN, Paduch DA. Yet another test of sperm chromatin structure. Fertil Steril. 2005 Oct;84(4):854-9. doi: 10.1016/j.fertnstert.2005.04.050.
- Background: PubMed 17644094Collins JA, Barnhart KT, Schlegel PN. Do sperm DNA integrity tests predict pregnancy with in vitro fertilization? Fertil Steril. 2008 Apr;89(4):823-31. doi: 10.1016/j.fertnstert.2007.04.055. Epub 2007 Jul 20.
- Background: PubMed 20447937Simon L, Brunborg G, Stevenson M, Lutton D, McManus J, Lewis SE. Clinical significance of sperm DNA damage in assisted reproduction outcome. Hum Reprod. 2010 Jul;25(7):1594-608. doi: 10.1093/humrep/deq103. Epub 2010 May 6.
- Background: PubMed 17579991Tarozzi N, Bizzaro D, Flamigni C, Borini A. Clinical relevance of sperm DNA damage in assisted reproduction. Reprod Biomed Online. 2007 Jun;14(6):746-57. doi: 10.1016/s1472-6483(10)60678-5.
- Background: PubMed 16940270Zini A, Libman J. Sperm DNA damage: clinical significance in the era of assisted reproduction. CMAJ. 2006 Aug 29;175(5):495-500. doi: 10.1503/cmaj.060218.
- Background: PubMed 15154089Sharma RK, Said T, Agarwal A. Sperm DNA damage and its clinical relevance in assessing reproductive outcome. Asian J Androl. 2004 Jun;6(2):139-48.
- Background: PubMed 20495207Speyer BE, Pizzey AR, Ranieri M, Joshi R, Delhanty JD, Serhal P. Fall in implantation rates following ICSI with sperm with high DNA fragmentation. Hum Reprod. 2010 Jul;25(7):1609-18. doi: 10.1093/humrep/deq116. Epub 2010 May 22.
- Background: PubMed 19304993Tsarev I, Bungum M, Giwercman A, Erenpreisa J, Ebessen T, Ernst E, Erenpreiss J. Evaluation of male fertility potential by Toluidine Blue test for sperm chromatin structure assessment. Hum Reprod. 2009 Jul;24(7):1569-74. doi: 10.1093/humrep/dep068. Epub 2009 Mar 21.
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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.
Avner E Hershlag, MD principal investigator
Center for Human Reproduction
1 site 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 and Unexplained Infertility, run by Northwell Health at 1 site 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 2 inclusion and 2 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 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pregnancy (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01232465, which also lists 12 linked publications.
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 Apr 2014.