Infertility, MaleNCT03129243
Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome
An observational study of Infertility, Male, run by Assiut University at 1 site in Egypt.
Trial summary
In the current era of assisted reproductive techniques where technology can help overcome defects in sperm function, the value of semen analysis has become even more inaccurate. Initial reports of intracytoplasmic sperm injection revealed its ability to bypass the natural selection process and enable men with severely… Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Sperm DNA integrity by flow cytometry
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 30 Oct 2019
- 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 20 to 50 years
- Men only
- No healthy volunteers
- Adult
Study population: The study will include all infertile couples undergoing intracytoplasmic sperm injection in The Department of Dermatology and Andrology with assisted reproductive unit at women's health hospital, Assiut University Hospital.
Who may be able to join
- Infertile male patients with abnormal semen parameters.
- Normal female partner aged <38 years.
Who cannot join
- Female patients with obvious infertility factor.
- Male patients with azoospermia.
- Male patients with systemic diseases.
- Male patients receiving cytotoxic therapy.
- Male patients with genital pathology as cryptorchidism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation of Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome in Couples With Male Infertility
In the current era of assisted reproductive techniques where technology can help overcome defects in sperm function, the value of semen analysis has become even more inaccurate. Initial reports of intracytoplasmic sperm injection revealed its ability to bypass the natural selection process and enable men with severely impaired semen parameters to achieve both clinical pregnancy and live birth
- Conditions
- Infertility, Male
- Being tested
- Sperm DNA integrity by flow cytometry
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm DNA integrity by flow cytometryDiagnostic test
flowcytometric test where sperm DNA breaks are evaluated indirectly through the DNA denaturability. The assay measures the susceptibility of sperm DNA to acid-induced DNA denaturation in situ, followed by staining with the fluorescence dye acridine orange. By using a flow cytometer 5.000-10.000 sperm can be analyzed within few seconds and thus provide a less subjective result compared to the World health organization analysis where only 1-300 cells are analyzed.
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Apr 2018
- Primary completion15 Sep 2019
- Study completion30 Oct 2019
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.
- More trials run by Assiut UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129243
- Sponsor's protocol ID
- ICSI
- Status last verified
- May 2020
- First submitted
- 23 Apr 2017
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome in Couples With Male Infertility
- ClinicalTrials.gov ID
- NCT03129243
- Acronym / sponsor ID
- ICSI
- Conditions
- Infertility, Male
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 26 Apr 2017 (actual)
- 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.
In the current era of assisted reproductive techniques where technology can help overcome defects in sperm function, the value of semen analysis has become even more inaccurate. Initial reports of intracytoplasmic sperm injection revealed its ability to bypass the natural selection process and enable men with severely impaired semen parameters to achieve both clinical pregnancy and live birth
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will include all infertile couples undergoing intracytoplasmic sperm injection in The Department of Dermatology and Andrology with assisted reproductive unit at women's health hospital, Assiut University Hospital.
Key inclusion criteria (2 listed)
- Infertile male patients with abnormal semen parameters.
- Normal female partner aged <38 years.
Key exclusion criteria (5 listed)
- Female patients with obvious infertility factor.
- Male patients with azoospermia.
- Male patients with systemic diseases.
- Male patients receiving cytotoxic therapy.
- Male patients with genital pathology as cryptorchidism.
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 |
|---|---|---|
| Sperm DNA integrity by flow cytometryflowcytometric test where sperm DNA breaks are evaluated indirectly through the DNA denaturability. The assay measures the susceptibility of sperm DNA to acid-induced DNA denaturation in situ, followed by staining with the fluorescence dye acridine orange. By using a flow cytometer 5.000-10.000 sperm can be analyzed within few seconds and thus provide a less subjective result compared to the World health organization analysis where only 1-300 cells are analyzed. | Diagnostic test | – |
Primary outcome
clinical pregnancy rate
Time frame: 4 weeks
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 28 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infertility, Male, run by Assiut University at 1 site in Egypt.
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 5 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 28 May 2020. 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 Egypt. 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?
clinical pregnancy rate (time frame: 4 weeks). 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 28 May 2020.