Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome

NCT03129243 | Completed

• 1 other identifier: ICSI
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility, Male

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  4 weeks

Interventions

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.

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: April 26, 2017
• Study Start: April 1, 2018
• Primary Completion: September 15, 2019
• Study Completion: October 30, 2019
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

EG (1)