Infertility, MaleNCT02058082
Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage
A study testing Intracytoplasmic sperm injection in people with Infertility, Male and DNA Damage, run by Mount Sinai Hospital, Canada.
Trial summary
The purpose of this study is to determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Infertility, Male, DNA Damage
- What is being tested?
- Intracytoplasmic sperm injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Dec 2011
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- be considered infertile (>1 year of unsuccessful attempts of conception
- Any race
- Male partner with persistent sperm DNA damage, DFI>=30%
- candidates for intracytoplasmic sperm injection (ICSI)
Who cannot join
- significant female factor infertility contributing to the couple's infertility
- female partner older than 38 years
- male or female patients with genetic abnormalities
- patients unable or unwilling to give consent after properly informed
- couples unsuitable for IVF/ICSI
- male patients in whom testicular procedures were contraindicated
About this study
Official title: Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for Men With High Sperm DNA Damage
The purpose of this study is to determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.
- Conditions
- Infertility, Male, DNA Damage
- Being tested
- Intracytoplasmic sperm injection
- Keywords
- Failure to Conceive Due to Infertility of Male Partner, DNA Damage
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracytoplasmic sperm injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ejaculated sperm | Active comparator | Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm Receives: Procedure: Intracytoplasmic sperm injection |
| testicular extracted sperm | Active comparator | Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm Receives: Procedure: Intracytoplasmic sperm injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rates
Measured: Up to 1 year
Secondary outcomes (7)
sperm DNA damage
Measured: Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure
oocyte fertilization rates
Measured: at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)
embryo cleavage rate
Measured: Day 3 post oocytes retrieval
blastocyst rate
Measured: Day 5 post oocytes retrieval
pregnancy rate
Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound
Measured: 6 to 8 week ultrasound
rate of spontaneous abortion
Measured: after a clinical pregnancy has been established, up to 10 months after procedure
birth defects
Measured: 1-year following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startJun 2005
- Primary completionJan 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirk Lo, Mount Sinai Hospital, Canada
- Investigators
- Kirk C. Lo, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058082
- Sponsor's protocol ID
- Sperm DNA damage study
- Status last verified
- Feb 2014
- First submitted
- 27 Jan 2014
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for Men With High Sperm DNA Damage
- ClinicalTrials.gov ID
- NCT02058082
- Acronym / sponsor ID
- Sperm DNA damage study
- Conditions
- Infertility, Male, DNA Damage
- Keywords
- Failure to Conceive Due to Infertility of Male Partner, DNA Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Feb 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 whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ejaculated sperm | Active comparator | Procedure: Intracytoplasmic sperm injectionIntracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm |
| testicular extracted sperm | Active comparator | Procedure: Intracytoplasmic sperm injectionIntracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- be considered infertile (>1 year of unsuccessful attempts of conception
- Any race
- Male partner with persistent sperm DNA damage, DFI>=30%
- candidates for intracytoplasmic sperm injection (ICSI)
Key exclusion criteria (6 listed)
- significant female factor infertility contributing to the couple's infertility
- female partner older than 38 years
- male or female patients with genetic abnormalities
- patients unable or unwilling to give consent after properly informed
- couples unsuitable for IVF/ICSI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracytoplasmic sperm injection | Procedure or surgery | ejaculated sperm, testicular extracted sperm |
Primary outcome
Live birth rates
Time frame: Up to 1 year
7 secondary outcomes
sperm DNA damage
Time frame: Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure
oocyte fertilization rates
Time frame: at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)
embryo cleavage rate
Time frame: Day 3 post oocytes retrieval
blastocyst rate
Time frame: Day 5 post oocytes retrieval
pregnancy rate
Time frame: 6 to 8 week ultrasound
rate of spontaneous abortion
Time frame: after a clinical pregnancy has been established, up to 10 months after procedure
birth defects
Time frame: 1-year following delivery
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 7 Feb 2014.
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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.
Kirk C. Lo, MD principal investigator
MOUNT SINAI HOSPITAL
Questions about this trial
What is this clinical trial studying?
A study testing Intracytoplasmic sperm injection in people with Infertility, Male and DNA Damage, run by Mount Sinai Hospital, Canada.
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 5 inclusion and 6 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 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Live birth rates (time frame: Up to 1 year). 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 7 Feb 2014.