Single Lumen Needle Without Flushing or Double Lumen Need... | NCT00995280

Studies
Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval

NCT00995280

Sponsor

Baskent University

Status

Completed

Last Update Posted

Oct 15, 2009Estimated

Enrollment

400Actual

Phase

Not Applicable

Conditions

Oocyte Retrieval

Interventions

single lumen needle oocyte retrieval
double lumen needle oocyte retrieval

Countries

Turkey (Türkiye)

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

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Oct 14, 2009

First Submission Date that Met QC Criteria

Oct 14, 2009

First Posted Date

Oct 15, 2009Estimated

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

Oct 14, 2009

Last Update Posted Date

Oct 15, 2009Estimated

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

The aim of this study is to compare whether oocyte flushing during retrieval is effective or not.

Detailed Description

In total 300 patients will be randomized for the effectiveness of single or double lumen needle during oocyte retrieval. Double lumen needles give an opportunity of washing to the follicle with flush. Single lumen needles seem to be faster and no need for flushing. We aim to compare to the differences of the use of both needles.

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

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Single lumen needle use in oocyte retrieval	Device: single lumen needle oocyte retrieval
2	Active Comparator	Double lumen needle with follicle flushing during oocyte retrieval	Device: double lumen needle oocyte retrieval

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single lumen needle oocyte retrieval	Device	single lumen needle use during oocyte retrieval	1

Measure	Description	Time Frame
Metaphase 2 oocyte number		6months

Measure	Description	Time Frame
clinical pregnancy rate		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing IVF/ICSI cycles.

Exclusion Criteria:

Poor responder patients who have lower than 6 follicles at hCG administration day.
Patients having over 30 follicles.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

41 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
Baskent University		Adana		01120	Turkey (Türkiye)