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

This study has been completed.

Sponsor:

Information provided by:

Baskent University

ClinicalTrials.gov Identifier:

NCT00995280

First received: October 14, 2009

Last updated: NA

Last verified: October 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	October 14, 2009
Last Updated Date	October 14, 2009
Start Date ^ICMJE	March 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 14, 2009)	Metaphase 2 oocyte number [ Time Frame: 6months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: October 14, 2009)	clinical pregnancy rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval
Official Title ^ICMJE	Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Condition ^ICMJE	Oocyte Retrieval
Intervention ^ICMJE	Device: single lumen needle oocyte retrieval single lumen needle use during oocyte retrieval Device: double lumen needle oocyte retrieval double lumen needle with 1 time follicle flushing with at least 2 ml during oocyte retrieval
Study Arm (s)	Active Comparator: 1 Single lumen needle use in oocyte retrieval Intervention: Device: single lumen needle oocyte retrieval Active Comparator: 2 Double lumen needle with follicle flushing during oocyte retrieval Intervention: Device: double lumen needle oocyte retrieval
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	400
Completion Date	November 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	20 Years to 41 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Turkey

Administrative Information
NCT Number ^ICMJE	NCT00995280
Other Study ID Numbers ^ICMJE	BHTB-03241705
Has Data Monitoring Committee	Yes
Responsible Party	No sponsor, Baskent University
Study Sponsor ^ICMJE	Baskent University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Baskent University
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top