Endometrial Assessment of Women With Uterine Infection | NCT03824184

Studies
Endometrial Assessment of Women With Uterine Infection

NCT03824184

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Sep 26, 2023Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

manipulation of endometrium

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

Sep 2023

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

Feb 2, 2019Actual

Primary Completion Date

May 3, 2024Estimated

Completion Date

Jun 20, 2024Estimated

First Submitted Date

Jan 28, 2019

First Submission Date that Met QC Criteria

Jan 29, 2019

First Posted Date

Jan 31, 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

Sep 23, 2023

Last Update Posted Date

Sep 26, 2023Actual

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

Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility .

Detailed Description

Implantation is the main rate limiting step in IVF outcome. Implantation is described at the cellular and the molecular levels by adhesion or fixation of a good quality embryo to receptive endometrium within a critical period of time, which is called the window of implantation

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hysteroscopic evaluation	Active Comparator	Hysteroscopic evaluation Active group : infection Manipulation of endometrium with saline	Procedure: manipulation of endometrium
control group	Other	Hysteroscopic evaluation Control group : No infection	Procedure: manipulation of endometrium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
manipulation of endometrium	Procedure	Manipulation of endometrium with saline	Hysteroscopic evaluation control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of women who will get pregnant after IUI	How many women will get pregnant after IUI	within 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with infertility age from 20-40 years

Exclusion Criteria:

Any factor of infertility

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

infertile women

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah and Kasralainy hospital	Recruiting	Giza			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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