Follicular Versus Luteal Pipelle in Repeated Implantation... | NCT01933893

Studies
Follicular Versus Luteal Pipelle in Repeated Implantation Failure Patients

NCT01933893

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Sep 2, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Repeated Implantation Failure

Interventions

Not provided

Countries

Not provided

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

May 2014Estimated

Completion Date

Not provided

First Submitted Date

Aug 29, 2013

First Submission Date that Met QC Criteria

Aug 29, 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

Aug 29, 2013

Last Update Posted Date

Sep 2, 2013Estimated

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

Pipelle was found to increase pregnancy and implantation rates in women undergoing IVF treatment in general, and in particular in repeated implantation failure (RIF). However, there is virtually no data regarding the optimal timing for the pipelle.

The current study aims to compare between follicular and luteal pipelle on pregnancy rate in RIF patients.

Detailed Description

Not provided

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

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Measure	Description	Time Frame
Pregnancy rate		April, 2014

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women diagnosed with RIF who are going to start a new IVF treatment

Exclusion Criteria:

Known hydrosalpinx body mass index (BMI) >29 kg/m2 or <18 kg/m2 Low ovarian response

Accepts Healthy Volunteers

Yes

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

Women diagnosed with repeated implantation failure (RIF) who are undergoing IVF treatment.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ido Ben-Ami, MD, PhD	Assaf Harofeh Medical Center, Zerifin, Israel	Principal Investigator

Locations

Not provided