Back to resultsIs There a Difference in Oocyte Quality? A Comparison of Two Aspiration Needle Gauges
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Oocyte Aspiration needle
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Fertility treatment
- Antral follicle count
Exclusion Criteria:
- Women who refuse to participate
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oocyte aspiration with 17G needle
Oocyte aspiration with (20-17G) needle
Arm Description
Oocyte Aspiration with 17G needle.
Oocyte Aspiration (20-17G) needle.
Outcomes
Primary Outcome Measures
Oocyte Quality microscopic description.
Aspirated oocytes from both needle gauges will be compared for quality according to 5 parameters: Polar body, Zona pellucida, Dark cytoplasm, Perivitelline space and Vacuoles.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02749773
Brief Title
Is There a Difference in Oocyte Quality? A Comparison of Two Aspiration Needle Gauges
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to determine whether different needle gauges influences the quality of the aspirated oocytes during in-vivo fertilization (IVF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oocyte aspiration with 17G needle
Arm Type
Active Comparator
Arm Description
Oocyte Aspiration with 17G needle.
Arm Title
Oocyte aspiration with (20-17G) needle
Arm Type
Active Comparator
Arm Description
Oocyte Aspiration (20-17G) needle.
Intervention Type
Device
Intervention Name(s)
Oocyte Aspiration needle
Intervention Description
Oocyte aspiration in women go through an IVF procedure,.
Primary Outcome Measure Information:
Title
Oocyte Quality microscopic description.
Description
Aspirated oocytes from both needle gauges will be compared for quality according to 5 parameters: Polar body, Zona pellucida, Dark cytoplasm, Perivitelline space and Vacuoles.
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fertility treatment
Antral follicle count
Exclusion Criteria:
Women who refuse to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Atzmon, MD
Email
atzmony@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuval Atzmon, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuval Atzmon, MD
Email
atzmony@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33171516
Citation
Atzmon Y, Michaeli M, Aslih N, Ruzov O, Rotfarb N, Shoshan-Karchovsky E, Shalom-Paz E. Degenerative Oocytes in the Aspirated Cohort Are Not Due to the Aspirating Needle: a Prospective Randomized Pilot Study with Sibling Oocytes. Reprod Sci. 2021 Jul;28(7):1882-1889. doi: 10.1007/s43032-020-00384-3. Epub 2020 Nov 10.
Results Reference
derived
Learn more about this trial
Is There a Difference in Oocyte Quality? A Comparison of Two Aspiration Needle Gauges
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