Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 180 for:    Phospholipids

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
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: Miscarriage

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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
Layout table for location contacts
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
Layout table for investigator information
Study Director: Hassan T Khairy, Professor Hassan Tawfik office

Layout table for additonal information
Responsible Party: Ahmed Mohamed Bahaa Eldin Ahmed, Clinical professor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03132779     History of Changes
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

Layout table for additional information
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:
Layout table for MeSH terms
Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions