Back to resultsIntralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortion
Primary Purpose
Recurrent Miscarriage
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Intralipid
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Miscarriage focused on measuring Intralipid, NK cells, Recurrent miscarriage
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One armed
Arm Description
One group of patient will take Intralipid for all
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03132779
First Posted
April 16, 2017
Last Updated
April 25, 2017
Sponsor
Ahmed Mohamed Bahaa Eldin Ahmed
Collaborators
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Anticipated)
Primary Completion Date
January 20, 2018 (Anticipated)
Study Completion Date
February 20, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Mohamed Bahaa Eldin Ahmed
Collaborators
Ain Shams Maternity Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Miscarriage
Keywords
Intralipid, NK cells, Recurrent miscarriage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Women with unexplained recurrent spontaneous abortions having increased NKcells activity
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One armed
Arm Type
Experimental
Arm Description
One group of patient will take Intralipid for all
Intervention Type
Drug
Intervention Name(s)
Intralipid
Other Intervention Name(s)
Intralipid 18 mg
Intervention Description
Adose of intralipid given and rechecking NKcells activity
Primary Outcome Measure Information:
Title
Change in NK cells activity after injection of intralipid
Description
NK cells is measured before and after injection of intralipid and is noticed for change in activity
Time Frame
One week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with recurrent spontaneous abortions
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sobhy R Mohammed, MBBCH
Phone
01003815460
Ext
002
Email
Garavandya@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M BahaaEldin, MD
Phone
01111700556
Ext
002
Email
abaha0503@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan T Khairy, Professor
Organizational Affiliation
Hassan Tawfik office
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortion
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