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

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ClinicalTrials.gov Identifier: NCT03132779
Recruitment Status : Unknown
Verified April 2017 by Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Ain Shams Maternity Hospital
Information provided by (Responsible Party):
Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital

Study Description
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Brief Summary:
Evaluating the effect of intralipid on the natural killer cells

Condition or disease Intervention/treatment Phase
Recurrent Miscarriage Drug: Intralipid Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Women with unexplained recurrent spontaneous abortions having increased NKcells activity
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortions
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : January 20, 2018
Estimated Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abortion Miscarriage

Arms and Interventions
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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 Name: Intralipid 18 mg


Outcome Measures
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Primary Outcome Measures :
  1. Change in NK cells activity after injection of intralipid [ Time Frame: One week ]
    NK cells is measured before and after injection of intralipid and is noticed for change in activity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with recurrent spontaneous abortions
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132779


Contacts
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Contact: Sobhy R Mohammed, MBBCH 01003815460 ext 002 Garavandya@hotmail.com
Contact: Ahmed M BahaaEldin, MD 01111700556 ext 002 abaha0503@yahoo.com

Sponsors and Collaborators
Ahmed Mohamed Bahaa Eldin Ahmed
Ain Shams Maternity Hospital
Investigators
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Study Director: Hassan T Khairy, Professor Hassan Tawfik office
More Information
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Responsible Party: Ahmed Mohamed Bahaa Eldin Ahmed, Clinical professor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03132779    
Other Study ID Numbers: Intralipid
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital:
Intralipid
NK cells
Recurrent miscarriage
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Recurrence
Disease Attributes
Pathologic Processes
 Pregnancy Complications
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions