## Protocol Section
### Identification Module
**NCT ID:** NCT03132779

**Brief Title:** Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortion

**Official Title:** Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortions

#### Organization Study ID Info
**ID:** Intralipid
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams Maternity Hospital
### Status Module
#### Completion Date
**Date:** 2018-02-20

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2017-04-28

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-25

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2018-01-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-05-01

**Type:** ESTIMATED

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2017-04-28
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-16
**Study First Submit QC Date:** 2017-04-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Ain Shams Maternity Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Ahmed Mohamed Bahaa Eldin Ahmed

#### Responsible Party

**Investigator Affiliation:** Ain Shams Maternity Hospital

**Investigator Full Name:** Ahmed Mohamed Bahaa Eldin Ahmed

**Investigator Title:** Clinical professor

**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:** Evaluating the effect of intralipid on the natural killer cells

**Detailed Description:** This study will done on women with recurrent spontaneous abortions having increased NKCELLS activity and evaluate the effect of Intralipid on them after re-estimation of NKcells activity again after one week of Intralipid adminstration

### Conditions Module

**Conditions:**

- Recurrent Miscarriage

**Keywords:**

- Intralipid

- NK cells

- Recurrent miscarriage

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Women with unexplained recurrent spontaneous abortions having increased NKcells activity

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 34

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** One group of patient will take Intralipid for all

**Intervention Names:**

- Drug: Intralipid

**Label:** One armed

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- One armed

**Description:** Adose of intralipid given and rechecking NKcells activity

**Name:** Intralipid

**Other Names:**

- Intralipid 18 mg

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** NK cells is measured before and after injection of intralipid and is noticed for change in activity

**Measure:** Change in NK cells activity after injection of intralipid

**Time Frame:** One week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* All women icluded having recurrent spontaneous abortions equal or more than twice.
* Alittle women having increased NKCELLS activity.

Exclusion Criteria:

* Any other diseases causing miscarriage as autoimmune (lupus erythematosus or antiphospholipid antibodies syndrome )or endocrinopathy (diabetes mellitus, thyroid disorders and hyperprolactinaemia)or thrombophilia (factor v leiden mutation, protein c or s deficiency, prothrombin G20210A mutation, antithrombin III deficiency ) or abnormal karyotyping to one or both of parents or previous history of hormonal contraception or intrauterine device usage at last 3 months or any contraindications for intralipid usage.

**Gender Based:** True

**Gender Description:** Women with recurrent spontaneous abortions

**Healthy Volunteers:** True

**Maximum Age:** 38 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Garavandya@hotmail.com

**Name:** Sobhy R Mohammed, MBBCH

**Phone:** 01003815460

**Phone Ext:** 002

**Role:** CONTACT

**Contact 2:**

**Email:** abaha0503@yahoo.com

**Name:** Ahmed M BahaaEldin, MD

**Phone:** 01111700556

**Phone Ext:** 002

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Hassan Tawfik office

**Name:** Hassan T Khairy, Professor

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

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

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrent

- ID: M21

- Name: Abortion, Spontaneous

- Relevance: HIGH

- As Found: Miscarriage

- ID: M25

- Name: Abortion, Habitual

- Relevance: HIGH

- As Found: Recurrent Miscarriage

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000022

- Term: Abortion, Spontaneous

- ID: D000000026

- Term: Abortion, Habitual

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Ancestors

- ID: D000005217

- Term: Fat Emulsions, Intravenous

- ID: D000057947

- Term: Parenteral Nutrition Solutions

- ID: D000019999

- Term: Pharmaceutical Solutions

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M223889

- Name: Soybean oil, phospholipid emulsion

- Relevance: HIGH

- As Found: Mimic

- ID: M8360

- Name: Fat Emulsions, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M28934

- Name: Parenteral Nutrition Solutions

- Relevance: LOW

- As Found: Unknown

- ID: T294

- Name: Soy Bean

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000545823

- Term: Soybean oil, phospholipid emulsion

### Misc Info Module

- Version Holder: 2024-05-24
