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Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome

Relation of Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome in Couples With Male Infertility

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03129243
Enrollment
120
Registered
2017-04-26
Start date
2018-04-01
Completion date
2019-10-30
Last updated
2020-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Male

Brief 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 impaired semen parameters to achieve both clinical pregnancy and live birth

Interventions

DIAGNOSTIC_TESTSperm DNA integrity by flow cytometry

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

1. Infertile male patients with abnormal semen parameters. 2. Normal female partner aged \<38 years.

Exclusion criteria

1. Female patients with obvious infertility factor. 2. Male patients with azoospermia. 3. Male patients with systemic diseases. 4. Male patients receiving cytotoxic therapy. 5. Male patients with genital pathology as cryptorchidism.

Design outcomes

Primary

MeasureTime frame
clinical pregnancy rate4 weeks

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026