Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles | NCT02245750

Studies
Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles

NCT02245750

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Sep 22, 2014Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

Hysteroscopy

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 2014

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

Aug 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Apr 24, 2014

First Submission Date that Met QC Criteria

Sep 19, 2014

First Posted Date

Sep 22, 2014Estimated

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 19, 2014

Last Update Posted Date

Sep 22, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

mostafa fouad, Value of Routine Hysteroscopy prior to IVF/ICSI Cycles: A Randomized Control Trial, Ain Shams Maternity HospitalPrincipal Investigator

Lead Sponsor

Ain Shams Maternity HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.

Detailed Description

A randomized controlled study involving 300 patients with recurrent implantation failure

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
Routine Invistigations	No Intervention	ICSI with long luteal phase protocol
Hysteroscopy	Experimental	hysteroscopy will be done prior to the ICSI cycle	Device: Hysteroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hysteroscopy	Device	hysteroscopy and endometrial injury prior to the IVF/ICSI cycle	Hysteroscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• Clinical pregnancy rate.		6 months

Secondary Outcomes

Measure	Description	Time Frame
• Live Birth Rate		6 months

Other Outcomes

Measure	Description	Time Frame
• Uterine anomalies detected by Hysteroscopy		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient's age ranged from 20-40 years.
Normal appearance of the uterine cavity on hysterosalpingography.
Patients prepared for IVF/ICSI cycle.

Exclusion Criteria:

Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of Pelvic Inflammatory Diseases).
Patients with uterine cavity pathology previously known to the examiner.
Patients with previous uterine surgery such as myomectomy.
Patients with abnormal HSG.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

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
Ahmed M Mohammed, MbbcH	Contact	00201110362860		ahmadmarzok85@gmail.com
mostafa f gomaa, MD	Contact	01226188993		mostafafouadg@gmail.com

Overall Officials

Name	Affiliation	Role
mostafa f gomaa, MD	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams Maternity 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
D015907	Hysteroscopy

Ancestor Terms

ID	Term
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided