Role of Immunoglobulin in Male Infertility

May 16, 2024 updated by: Dr Salma kafeel Qureshi
to investigate the role of IVIG in male infertility and to determine its benefits in term of semen parameters and assisted reproduction outcome

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Capital
      • Islamabad, Capital, Pakistan, 44000
        • Recruiting
        • SKMC
        • Contact:
          • dr riffat, PhD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • male patients

Exclusion Criteria:

  • female

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: male fertility
Combination product: IVIG
treatment of subfertility
Other Names:
  • pentaglobin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semen parameters percentage improvement
Time Frame: 6 month
Sperm concentration/ml
6 month
Sperm motility
Time Frame: 6 month
Percentage active motile sperm
6 month
Sperm morphology
Time Frame: 6 month
Percentage of normal sperm
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assisted Reproduction outcome measure
Time Frame: 12 months
Percentage of fertilized
12 months

Collaborators and Investigators

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

Sponsor

Dr Salma kafeel Qureshi

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, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

with in 6 month

IPD Sharing Time Frame

6 month

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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