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
  Purpose

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


Condition Intervention
Oocyte Retrieval
Device: single lumen needle oocyte retrieval
Device: double lumen needle oocyte retrieval

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval

Further study details as provided by Baskent University:

Primary Outcome Measures:
  • Metaphase 2 oocyte number [ Time Frame: 6months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical pregnancy rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 400
Study Start Date: March 2008
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 41 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995280

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

No publications provided

Responsible Party: No sponsor, Baskent University
ClinicalTrials.gov Identifier: NCT00995280     History of Changes
Other Study ID Numbers: BHTB-03241705
Study First Received: October 14, 2009
Last Updated: October 14, 2009
Health Authority: Turkey: Ethics Committee

Keywords provided by Baskent University:
follicle flushing
oocyte retrieval
needle

Additional relevant MeSH terms:
Flushing
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014