Intralipid Related Effect on NKcells in Patients With Une... | NCT03132779

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

NCT03132779

Sponsor

Ahmed Mohamed Bahaa Eldin Ahmed

Status

Unknown status

Last Update Posted

Apr 28, 2017Actual

Enrollment

34Estimated

Phase

Phase 1

Conditions

Recurrent Miscarriage

Interventions

Intralipid

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Estimated

Primary Completion Date

Jan 20, 2018Estimated

Completion Date

Feb 20, 2018Estimated

First Submitted Date

Apr 16, 2017

First Submission Date that Met QC Criteria

Apr 25, 2017

First Posted Date

Apr 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2017

Last Update Posted Date

Apr 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Mohamed Bahaa Eldin Ahmed, Clinical professor, Ain Shams Maternity HospitalSponsor-Investigator

Lead Sponsor

Ahmed Mohamed Bahaa Eldin AhmedOTHER

Collaborators

Name	Class
Ain Shams Maternity Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluating the effect of intralipid on the natural killer cells

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One armed	Experimental	One group of patient will take Intralipid for all	Drug: Intralipid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intralipid	Drug	Adose of intralipid given and rechecking NKcells activity	One armed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women with recurrent spontaneous abortions

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sobhy R Mohammed, MBBCH	Contact	01003815460	002	Garavandya@hotmail.com
Ahmed M BahaaEldin, MD	Contact	01111700556	002	abaha0503@yahoo.com

Overall Officials

Name	Affiliation	Role
Hassan T Khairy, Professor	Hassan Tawfik office	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000026	Abortion, Habitual

Ancestor Terms

ID	Term
D000022	Abortion, Spontaneous
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C545823	soybean oil, phospholipid emulsion

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided