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

NCT ID: NCT03132779

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-02-20

Brief Summary

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Evaluating the effect of intralipid on the natural killer cells

Detailed Description

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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

Conditions

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Recurrent Miscarriage

Keywords

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Intralipid NK cells Recurrent miscarriage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Women with unexplained recurrent spontaneous abortions having increased NKcells activity
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One armed

One group of patient will take Intralipid for all

Group Type EXPERIMENTAL

Intralipid

Intervention Type DRUG

Adose of intralipid given and rechecking NKcells activity

Interventions

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Intralipid

Adose of intralipid given and rechecking NKcells activity

Intervention Type DRUG

Other Intervention Names

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Intralipid 18 mg

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role collaborator

Ahmed Mohamed Bahaa Eldin Ahmed

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Bahaa Eldin Ahmed

Clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hassan T Khairy, Professor

Role: STUDY_DIRECTOR

Hassan Tawfik office

Central Contacts

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Sobhy R Mohammed, MBBCH

Role: CONTACT

Phone: 01003815460

Email: [email protected]

Ahmed M BahaaEldin, MD

Role: CONTACT

Phone: 01111700556

Email: [email protected]

Other Identifiers

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Intralipid

Identifier Type: -

Identifier Source: org_study_id