A Therapeutic Protocol in Previous Failed ART Patients Wi... | NCT03792997

Studies
A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells

NCT03792997

Sponsor

Benha University

Status

Completed

Last Update Posted

Jan 3, 2022Actual

Enrollment

100Actual

Phase

Phase 2

Conditions

Unexplained Infertility

Interventions

combination therapy for high peripheral NK cells

Countries

Egypt

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 15, 2019Actual

Completion Date

Dec 10, 2021Actual

First Submitted Date

Jan 2, 2019

First Submission Date that Met QC Criteria

Jan 3, 2019

First Posted Date

Jan 4, 2019Actual

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

Dec 13, 2021

Last Update Posted Date

Jan 3, 2022Actual

Name	Class
Hawaa Fertility Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion &prednisolone & LMWH

Detailed Description

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	Active Comparator	regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid	Combination Product: combination therapy for high peripheral NK cells
study	Experimental	regular treatment with embryo transfer in the form of progesterone I.M. & Supp. in addition to low dose aspirin & folic acid but the investigators add in this arm lipid emulsion & prednisolone & LMWH	Combination Product: combination therapy for high peripheral NK cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
combination therapy for high peripheral NK cells	Combination Product	lipid emulsion & prednisolone & LMWH	control study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
chemical pregnancy rate	quantitative serum test	14 days

Secondary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate	gestational sac and fetal echo by ultrasound	6 weeks of pregnancy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with high peripheral NK cells > 10% unexplained infertility cases cases with endometriosis

Exclusion Criteria:

uterine factors poor responders< 3 MII oocytes severe male factor & Azospermia

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Infertile females undergoing ART cycles

Minimum Age

20 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ahmed sa saad, MD, ph D	Hawaa Fertility Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banha University- Hawaa Fertility center		Banhā	Qalyubia Governorate	13512	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

study protocol, statistical analysis & results

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

1 month after publication, for 6 months

Access Criteria

for researchers doing metanalysis.by contacting us by email

URL

Not provided