NCT03132779

Brief Summary

Evaluating the effect of intralipid on the natural killer cells

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

April 16, 2017

Last Update Submit

April 25, 2017

Conditions

Recurrent Miscarriage

Keywords

IntralipidNK cellsRecurrent miscarriage

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

One armed

EXPERIMENTAL

One group of patient will take Intralipid for all

Drug: Intralipid

Interventions

IntralipidDRUG

Adose of intralipid given and rechecking NKcells activity

Also known as: Intralipid 18 mg
One armed

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with recurrent spontaneous abortions
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All women icluded having recurrent spontaneous abortions equal or more than twice.
  • Alittle women having increased NKCELLS activity.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abortion, Habitual

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Hassan T Khairy, Professor

    Hassan Tawfik office

    STUDY DIRECTOR

Central Study Contacts

Sobhy R Mohammed, MBBCH

CONTACT

01003815460Garavandya@hotmail.com

Ahmed M BahaaEldin, MD

CONTACT

01111700556abaha0503@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Women with unexplained recurrent spontaneous abortions having increased NKcells activity
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

April 16, 2017

First Posted

April 28, 2017

Study Start

May 1, 2017

Primary Completion

January 20, 2018

Study Completion

February 20, 2018

Last Updated

April 28, 2017

Record last verified: 2017-04