Back to resultsFollicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients (needles(opu))
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
single lumen needle in oocyte retrieval
double lumen needle in oocyte retrieval
Sponsored by
About this trial
This is an interventional health services research trial for Infertility focused on measuring follicular flushing, IVF, poor responders, oocyte retrival
Eligibility Criteria
Inclusion Criteria:
- women between 20-45 years old
- the number of follicles less than 5 on the day of HCG administration
- the value of progesteron on the day of hCG administration must be under 1.5ng/ml
Exclusion Criteria:
- women under 20 years and older than 45 year
- on the day of hCG administration if the follicle number is more than 5
- if.the value of progesteron on the day of hCG administration is higher than 1.5ng/ml
Sites / Locations
- Bulent Haydardedeoglu
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
single lumen
double lumen
Arm Description
Single lumen needle in oocyte retrieval
Double lumen needle with follicle flushing during oocyte retrieval
Outcomes
Primary Outcome Measures
number of metaphase 2 oocyte
Secondary Outcome Measures
clinical pregnancy rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02391155
Brief Title
Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients
Acronym
needles(opu)
Official Title
Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients:a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, the investigators aimed to evaluate to the efficacy of the needle type used in follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.
Detailed Description
This study will include:
women with less than four follicles on the day of hCG administration
women between 20-45 age old
The value of progesterone on the day of hCG administration will be under 1.5ng/ml
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
follicular flushing, IVF, poor responders, oocyte retrival
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single lumen
Arm Type
Active Comparator
Arm Description
Single lumen needle in oocyte retrieval
Arm Title
double lumen
Arm Type
Active Comparator
Arm Description
Double lumen needle with follicle flushing during oocyte retrieval
Intervention Type
Procedure
Intervention Name(s)
single lumen needle in oocyte retrieval
Intervention Description
single lumen needle use during oocyte retrieval
Intervention Type
Procedure
Intervention Name(s)
double lumen needle in oocyte retrieval
Intervention Description
after aspiration of follicles, 3 times flushing will be performed in double lumen needle.
Primary Outcome Measure Information:
Title
number of metaphase 2 oocyte
Time Frame
Six months
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Time Frame
eigth months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women between 20-45 years old
the number of follicles less than 5 on the day of HCG administration
the value of progesteron on the day of hCG administration must be under 1.5ng/ml
Exclusion Criteria:
women under 20 years and older than 45 year
on the day of hCG administration if the follicle number is more than 5
if.the value of progesteron on the day of hCG administration is higher than 1.5ng/ml
Facility Information:
Facility Name
Bulent Haydardedeoglu
City
Adana
ZIP/Postal Code
01120
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients
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