Role of Immunoglobulin in Male Infertility | NCT06423989

Studies
Role of Immunoglobulin in Male Infertility

NCT06423989

Sponsor

Dr Salma kafeel Qureshi

Status

Unknown status

Last Update Posted

May 21, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Male Subfertility

Interventions

IVIG

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Apr 17, 2024

First Submission Date that Met QC Criteria

May 16, 2024

First Posted Date

May 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2024

Last Update Posted Date

May 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Salma kafeel Qureshi, Medical director head of Gynaecological and Reproductive unit, Salma Kafeel Medical CentreSponsor-Investigator

Lead Sponsor

Dr Salma kafeel QureshiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
male fertility	Experimental		Combination Product: IVIG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IVIG	Combination Product	treatment of subfertility	male fertility

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male patients

Exclusion Criteria:

female

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DR Riffat, PhD	Contact	00923225041390		rifat.skmc@gmail.com
DR Riffat, PhD	Contact	00923225041390		riffat.skmc@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SKMC	Recruiting	Islamabad	Capital	44000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

with in 6 month

Types

Study Protocol

Time Frame

6 month

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016756	Immunoglobulins, Intravenous
C060166	pentaglobulin

Ancestor Terms

ID	Term
D007074	Immunoglobulin G
D007132	Immunoglobulin Isotypes
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided