Assessment of Endometrial Pattern and Sub-endometrial Vas... | NCT03683771

Studies
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome

NCT03683771

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Jan 9, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Infertility

Interventions

Transvaginal US with Doppler study

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2018Actual

Primary Completion Date

Feb 15, 2019Estimated

Completion Date

Feb 20, 2019Estimated

First Submitted Date

Sep 22, 2018

First Submission Date that Met QC Criteria

Sep 22, 2018

First Posted Date

Sep 25, 2018Actual

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

Jan 8, 2019

Last Update Posted Date

Jan 9, 2019Actual

Name	Class
Kasr El Aini Hospital	OTHER
National Research Centre, Egypt	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

Despite constant progress in in vitro fertilization (IVF) techniques and ovarian stimulation, pregnancy and embryo implantation rates remain modest . The phenomenon of embryo implantation depends both on the embryo itself and on endometrial receptivity

Detailed Description

A favorable uterine medium is necessary for embryo implantation, but endometrial receptivity can be negatively affected by ovarian stimulation . Study of endometrial receptivity is especially limited in the context of IVF cycles .

Biopsy of the endometrium cannot be considered during the treatment, and this has encouraged the development and use of ultrasonography and Doppler-like non-invasive methods to evaluate ovarian response to the stimulation and uterine receptivity .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transvaginal US with Doppler study	Diagnostic Test	Transvaginal Ultrasound with doppler study on endometrium will be made

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of patients who will have positive pregnancy rate	patients who will get pregnant in ICSI cycle with measuring their doppler indices before ovum pick up	within 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Maternal age from 20 to 40 years. Women with BMI range from 20 - 35 Women diagnosed with primary infertility

Exclusion Criteria:

Maternal chronic medical disorder (diabetes mellitus or hypertension). Women diagnosed with autoimmune diseases or antiphospholipid syndrome

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

infertile women who will undergo ICSI

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

120 patients will be included in the study whom will meet the inclusion criteria.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy	Contact	01002611058		mahmoudalalfy@ymail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy	Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasralainy hospital	Recruiting	Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015150	Echocardiography, Doppler

Ancestor Terms

ID	Term
D004452	Echocardiography
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided