NCT00995280

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
Last Updated

October 15, 2009

Status Verified

October 1, 2009

Enrollment Period

6 months

First QC Date

October 14, 2009

Last Update Submit

October 14, 2009

Conditions

Oocyte Retrieval

Keywords

follicle flushingoocyte retrievalneedle

Outcome Measures

Primary Outcomes (1)

  • Metaphase 2 oocyte number

    6months

Secondary Outcomes (1)

  • clinical pregnancy rate

    6 months

Study Arms (2)

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

single lumen needle oocyte retrievalDEVICE

single lumen needle use during oocyte retrieval

1
double lumen needle oocyte retrievalDEVICE

double lumen needle with 1 time follicle flushing with at least 2 ml during oocyte retrieval

2

Eligibility Criteria

Age20 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing IVF/ICSI cycles.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Adana, 01120, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

March 1, 2008

Primary Completion

September 1, 2008

Study Completion

November 1, 2008

Last Updated

October 15, 2009

Record last verified: 2009-10

Locations

TU(1)