Intrauterine Injection of HCG and Implantation Rate | NCT01933126

Studies
Intrauterine Injection of HCG and Implantation Rate

NCT01933126

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Feb 19, 2014Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Pregnancy Rate
Implantation Rate

Interventions

HCG injection
Placebo

Countries

Israel

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

Feb 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 2013

Primary Completion Date

Oct 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Feb 28, 2013

First Submission Date that Met QC Criteria

Aug 30, 2013

First Posted Date

Sep 2, 2013Estimated

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

Feb 18, 2014

Last Update Posted Date

Feb 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Assaf Harofeh MC, Assaf Harofeh Medical Center, Assaf-Harofeh Medical CenterPrincipal Investigator

Lead Sponsor

Assaf-Harofeh Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The study aims to examine the effect of intrauterine injection of HCG on pregnany rate in women undergoing IVF treatment.

Detailed Description

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCG administration	Experimental	Intrauterine HCG injection	Drug: HCG injection
Placebo	Placebo Comparator	G2 Medium	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HCG injection	Drug		HCG administration
Placebo

Measure	Description	Time Frame
Pregnancy rate		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women undergoing IVF treatment

Exclusion Criteria:

> 40 years

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofeh Medical Center	Recruiting	Be’er Ya‘aqov	Zerifin	70300	Israel