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NCT03132779 Clinical Trial

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

Recurrent Miscarriage Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03132779
Other study ID # Intralipid
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received April 16, 2017
Last updated April 25, 2017
Start date May 1, 2017
Est. completion date February 20, 2018

Study information
Verified date April 2017
Source Ain Shams Maternity Hospital
Contact Sobhy R Mohammed, MBBCH
Phone 01003815460
Email Garavandya@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluating the effect of intralipid on the natural killer cells

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 34
Est. completion date February 20, 2018
Est. primary completion date January 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 38 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Intralipid
Adose of intralipid given and rechecking NKcells activity

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ahmed Mohamed Bahaa Eldin Ahmed Ain Shams Maternity Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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