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Comparison of 2 Different Flow Rates During Oocyte Retrieval

Primary Purpose

Infertility

Status
Not yet recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Oocyte retrieval with low aspiration flow rate
Oocyte retrieval with high aspiration flow rate
Sponsored by
Eugonia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Flow rate, Aspiration pressure, Oocyte retrieval

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Presence of both ovaries 18-43 years old At least two follicles >14mm present in each ovary on day of triggering final oocyte maturation. Exclusion Criteria: One or no ovaries present Monofollicular development Poor responders Previous history of hemorrhage during oocyte retrieval

Sites / Locations

  • Eugonia Unit of Assisted Reproduction

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low aspiration flow rate

High aspiration flow rate

Arm Description

All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec.

All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec.

Outcomes

Primary Outcome Measures

Number of oocytes retrieved
Number of oocytes retrieved per ovary randomised.

Secondary Outcome Measures

Oocyte recovery rate
Number of oocytes retrieved per follicle aspirated.
Oocyte maturation rate
Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised.
Average oocyte score
Average oocyte score based on the evaluation of oocyte shape and size, ooplasm characteristics, structure of perivitelline space, structure of zona pellucida and polar body morphology.
Fertilization rate
Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised.
Percentage of good quality blastocysts on day 5
Number of good quality blastocysts divided by the number of fertilized oocytes per ovary randomised.

Full Information

First Posted
August 8, 2023
Last Updated
August 31, 2023
Sponsor
Eugonia
Collaborators
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT06019494
Brief Title
Comparison of 2 Different Flow Rates During Oocyte Retrieval
Official Title
Is Flow Rate During Oocyte Retrieval Associated With the Number of Oocytes Retrieved? A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eugonia
Collaborators
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of different flow rates during oocyte retrieval, on the number of cumulus oocyte complexes (COCs) retrieved.
Detailed Description
In the current study, each ovary will be randomly allocated to oocyte retrieval using 0.42 ml/sec or 0.62 ml/sec flow rate. The primary endpoint will be the number of oocytes retrieved, while secondary outcomes will include oocyte recovery rate (number of oocytes retrieved per follicle aspirated), number of mature oocytes, maturation rate (number of mature oocytes/number of oocytes retrieved), mean oocyte score (by evaluating oocyte shape and size, ooplasm characteristics, structure of perivitelline space (PVS), structure of zona pellucida (ZP) and polar body (PB) morphology), fertilization rate (number of fertilized oocytes/number of mature oocytes), number of blastocysts and blastulation rate (number of blastocysts/number of 2PN). Patients aged <43 years with the presence of at least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval will be eligible for inclusion in the study. Prior to oocyte retrieval in eligible patients their left and right ovary will be randomly allocated into the 0.42 ml/sec or 0.62 ml/sec flow rate group. Randomisation with minimisation will be employed. The specific flow rates will be achieved by adjusting the aspiration pressure of the vacuum pump accordingly. A study nurse will be responsible for adjusting the aspiration pressure of the vacuum pump depending on randomization. The doctor performing the oocyte retrieval will not be aware of the flow rate used in each ovary. All follicles will be aspirated and then flushed if needed up to a maximum of 5 times with an open flushing technique, using a 17G double-lumen needle. Data will be registered regarding the number of flushes required to retrieve a COC, the morphology of oocytes after denudation, oocyte fertilisation and embryo development up to the blastocyst stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Flow rate, Aspiration pressure, Oocyte retrieval

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low aspiration flow rate
Arm Type
Experimental
Arm Description
All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec.
Arm Title
High aspiration flow rate
Arm Type
Experimental
Arm Description
All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec.
Intervention Type
Procedure
Intervention Name(s)
Oocyte retrieval with low aspiration flow rate
Intervention Description
All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.42 ml/sec.
Intervention Type
Procedure
Intervention Name(s)
Oocyte retrieval with high aspiration flow rate
Intervention Description
High aspiration flow rate All follicles will be aspirated with the addition of follicular flushing if necessary (up to 5 times per follicle) with an aspiration flow rate of 0.62 ml/sec.
Primary Outcome Measure Information:
Title
Number of oocytes retrieved
Description
Number of oocytes retrieved per ovary randomised.
Time Frame
During oocyte retrieval
Secondary Outcome Measure Information:
Title
Oocyte recovery rate
Description
Number of oocytes retrieved per follicle aspirated.
Time Frame
During oocyte retrieval
Title
Oocyte maturation rate
Description
Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised.
Time Frame
2-3 hours post oocyte retrieval
Title
Average oocyte score
Description
Average oocyte score based on the evaluation of oocyte shape and size, ooplasm characteristics, structure of perivitelline space, structure of zona pellucida and polar body morphology.
Time Frame
2-3 hours post oocyte retrieval
Title
Fertilization rate
Description
Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised.
Time Frame
Day 1 post oocyte retrieval
Title
Percentage of good quality blastocysts on day 5
Description
Number of good quality blastocysts divided by the number of fertilized oocytes per ovary randomised.
Time Frame
5 days post oocyte retrieval

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must have both ovaries present
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Presence of both ovaries 18-43 years old At least two follicles >14mm present in each ovary on day of triggering final oocyte maturation. Exclusion Criteria: One or no ovaries present Monofollicular development Poor responders Previous history of hemorrhage during oocyte retrieval
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George T Lainas, PhD
Phone
+302107236333
Email
ggslns@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tryfon G Lainas, PhD
Phone
+302107236333
Email
tlainas@eugonia.com.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George T Lainas, PhD
Organizational Affiliation
Eugonia ART Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eugonia Unit of Assisted Reproduction
City
Athens
ZIP/Postal Code
11528
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26630267
Citation
Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.
Results Reference
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Comparison of 2 Different Flow Rates During Oocyte Retrieval

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