## Protocol Section
### Identification Module
**NCT ID:** NCT06423989

**Brief Title:** Role of Immunoglobulin in Male Infertility

**Official Title:** Role of Immunoglobulin in Male Infertility

#### Organization Study ID Info
**ID:** 102023
#### Organization
**Class:** OTHER
**Full Name:** Salma Kafeel Medical Centre
### Status Module
#### Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-17
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dr Salma kafeel Qureshi

#### Responsible Party

**Investigator Affiliation:** Salma Kafeel Medical Centre

**Investigator Full Name:** Dr Salma kafeel Qureshi

**Investigator Title:** Medical director head of Gynaecological and Reproductive unit

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### 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

### Conditions Module

**Conditions:**

- Male Subfertility

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Combination Product: IVIG

**Label:** male fertility

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- male fertility

**Description:** treatment of subfertility

**Name:** IVIG

**Other Names:**

- pentaglobin

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** Sperm concentration/ml

**Measure:** Semen parameters percentage improvement

**Time Frame:** 6 month

**Description:** Percentage active motile sperm

**Measure:** Sperm motility

**Time Frame:** 6 month

**Description:** Percentage of normal sperm

**Measure:** Sperm morphology

**Time Frame:** 6 month

#### Secondary Outcomes

**Description:** Percentage of fertilized

**Measure:** Assisted Reproduction outcome measure

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* male patients

Exclusion Criteria:

* female

**Healthy Volunteers:** True

**Sex:** MALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rifat.skmc@gmail.com

**Name:** DR Riffat, PhD

**Phone:** 00923225041390

**Role:** CONTACT

**Contact 2:**

**Email:** riffat.skmc@gmail.com

**Name:** DR Riffat, PhD

**Phone:** 00923225041390

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Islamabad

**Contacts:**

***Contact 1:***

- **Name:** dr riffat, PhD

- **Role:** CONTACT

**Country:** Pakistan

**Facility:** SKMC

**State:** Capital

**Status:** RECRUITING

**Zip:** 44000

### IPD Sharing Statement Module

**Description:** with in 6 month

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** 6 month

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10290

- Name: Infertility

- Relevance: HIGH

- As Found: Infertility

- ID: M10292

- Name: Infertility, Male

- Relevance: HIGH

- As Found: Male Infertility

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007246

- Term: Infertility

- ID: D000007248

- Term: Infertility, Male

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
