NCT06423989

Brief Summary

to investigate the role of IVIG in male infertility and to determine its benefits in term of semen parameters and assisted reproduction outcome

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 17, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

April 17, 2024

Last Update Submit

May 16, 2024

Conditions

Male Subfertility

Outcome Measures

Primary Outcomes (3)

  • Semen parameters percentage improvement

    Sperm concentration/ml

    6 month

  • Sperm motility

    Percentage active motile sperm

    6 month

  • Sperm morphology

    Percentage of normal sperm

    6 month

Secondary Outcomes (1)

  • Assisted Reproduction outcome measure

    12 months

Study Arms (1)

male fertility

EXPERIMENTAL
Combination Product: IVIG

Interventions

IVIGCOMBINATION_PRODUCT

treatment of subfertility

Also known as: pentaglobin
male fertility

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • male patients

You may not qualify if:

  • female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKMC

Islamabad, Capital, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Interventions

Immunoglobulins, Intravenouspentaglobulin

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

DR Riffat, PhD

CONTACT

00923225041390rifat.skmc@gmail.com

DR Riffat, PhD

CONTACT

00923225041390riffat.skmc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical director head of Gynaecological and Reproductive unit

Study Record Dates

First Submitted

April 17, 2024

First Posted

May 21, 2024

Study Start

April 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

with in 6 month

Shared Documents
STUDY PROTOCOL
Time Frame
6 month

Locations

PA(1)