Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-10-30

Brief Summary

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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

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Detailed Description

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Conditions

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Infertility, Male

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Sperm 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No