Sperm DNA Damage to Intracytoplasmic Sperm Injection Outcome

May 26, 2020 updated by: Ahmed Mohamed Abbas, Assiut University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Assiut, Cairo, Egypt, 002
        • Ahmed Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical pregnancy rate
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

September 15, 2019

Study Completion (ACTUAL)

October 30, 2019

Study Registration Dates

First Submitted

April 23, 2017

First Submitted That Met QC Criteria

April 23, 2017

First Posted (ACTUAL)

April 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICSI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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