Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortion

Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortions

Evaluating the effect of intralipid on the natural killer cells

Study Overview

• Status: Unknown
• Conditions: Recurrent Miscarriage
• Intervention / Treatment: Drug: Intralipid

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

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sobhy R Mohammed, MBBCH; Phone Number: 002 01003815460; Email: Garavandya@hotmail.com
• Study Contact Backup: Name: Ahmed M BahaaEldin, MD; Phone Number: 002 01111700556; Email: abaha0503@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One armed; One group of patient will take Intralipid for all	Drug: Intralipid; Adose of intralipid given and rechecking NKcells activity; Other Names: Intralipid 18 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in NK cells activity after injection of intralipid	NK cells is measured before and after injection of intralipid and is noticed for change in activity	One week

Collaborators and Investigators

• Sponsor: Ahmed Mohamed Bahaa Eldin Ahmed
• Collaborators: Ain Shams Maternity Hospital
• Investigators: Study Director: Hassan T Khairy, Professor, Hassan Tawfik office

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2017
• Primary Completion (Anticipated): January 20, 2018
• Study Completion (Anticipated): February 20, 2018

Study Registration Dates

• First Submitted: April 16, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Intralipid; NK cells; Recurrent miscarriage
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Recurrence; Abortion, Spontaneous; Abortion, Habitual; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: Intralipid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

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