Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome

Infertility, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129243
• Other study ID #: ICSI
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 30, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate		4 weeks