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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00995280
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The aim of this study is to compare whether oocyte flushing during retrieval is effective or not.

Condition or disease Intervention/treatment
Oocyte Retrieval Device: single lumen needle oocyte retrieval Device: double lumen needle oocyte retrieval

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval
Study Start Date : March 2008
Primary Completion Date : September 2008
Study Completion Date : November 2008
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Single lumen needle use in oocyte retrieval
Device: single lumen needle oocyte retrieval
single lumen needle use during oocyte retrieval
Active Comparator: 2
Double lumen needle with follicle flushing 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


Outcome Measures

Primary Outcome Measures :
  1. Metaphase 2 oocyte number [ Time Frame: 6months ]

Secondary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995280


Locations
Turkey
Baskent University
Adana, Turkey, 01120
Sponsors and Collaborators
Baskent University
More Information

Responsible Party: No sponsor, Baskent University
ClinicalTrials.gov Identifier: NCT00995280     History of Changes
Other Study ID Numbers: BHTB-03241705
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

Keywords provided by Baskent University:
follicle flushing
oocyte retrieval
needle

Additional relevant MeSH terms:
Flushing
Signs and Symptoms