Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome

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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Key information

Conditions

Infertility, Male Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Sperm DNA integrity by flow cytometry

Diagnostic 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.

Primary outcomes

clinical pregnancy rate

Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Apr 26, 2017
Registry last updated: May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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