Prevalence of Mullerian Anomalies in Infertile Women | NCT03498079

Studies
Prevalence of Mullerian Anomalies in Infertile Women

NCT03498079

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Jan 9, 2019Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Mullerian Anomaly of Uterus

Interventions

3D ultrasound

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

Apr 16, 2018Actual

Primary Completion Date

Apr 20, 2019Estimated

Completion Date

Apr 25, 2019Estimated

First Submitted Date

Apr 7, 2018

First Submission Date that Met QC Criteria

Apr 12, 2018

First Posted Date

Apr 13, 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

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Alalfy, Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital, Aljazeera HospitalPrincipal Investigator

Lead Sponsor

Aljazeera HospitalOTHER

Collaborators

Name	Class
Kasr El Aini Hospital	OTHER
National Research Centre, Egypt	OTHER
misr Infertility centre ,Alaqsor	UNKNOWN

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

Mullerian anomalies are congenital structural anomalies in the uterus .
Its prevalence is not uncommon .

Detailed Description

PCO is very common in gynecological practice
Women with mullerian anomalies should be properly evaluated for other gynecological and urological problems

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D ultrasound	Diagnostic Test	3D ultrasound will be done to females complaining from primary infertility with mullerian anomalies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of participants who will prove to have PCO	diagnosis of PCO by US and by FSH and LH levels	within 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

females with age between 20-42 years with primary infertility

Exclusion Criteria:

females with age above 42 years or below 20 years females with secondary infertility

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

females with primary infertility

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

- females with age between 20-42 years with primary infertility

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	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah	Recruiting	Giza			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

we will publish the results which will be obtained from this study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided