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

Oocyte Retrieval Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995280
• Other study ID #: BHTB-03241705
• Status: Completed
• Phase: N/A
• First received: October 14, 2009
• Last updated: October 14, 2009
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: October 2009
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 41 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Flushing
• Oocyte Retrieval

Intervention

Device:
• single lumen needle oocyte retrieval
single lumen needle use during oocyte retrieval
• double lumen needle oocyte retrieval
double lumen needle with 1 time follicle flushing with at least 2 ml during oocyte retrieval

Locations

Country	Name	City	State
Turkey	Baskent University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metaphase 2 oocyte number		6months	Yes
Secondary	clinical pregnancy rate		6 months	Yes