Comparison of 2 Different Flow Rates During Oocyte Retrieval

February 6, 2024 updated by: Eugonia

Is Flow Rate During Oocyte Retrieval Associated With the Number of Oocytes Retrieved? A Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 18-43 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 16G 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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Eugonia Unit of Assisted Reproduction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Presence of both ovaries
  • 18-43 years old
  • At least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval

Exclusion Criteria:

  • One or no ovaries present
  • Monofollicular development
  • Poor responders
  • Previous history of hemorrhage during oocyte retrieval

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low aspiration flow rate
All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec.
Procedure: Oocyte retrieval with low 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 0.42 ml/sec.
Experimental: High aspiration flow rate
All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec.
Procedure: Oocyte retrieval with high aspiration flow rate
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of oocytes retrieved
Time Frame: During oocyte retrieval
Number of oocytes retrieved per ovary randomised.
During oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte recovery rate
Time Frame: During oocyte retrieval
Number of oocytes retrieved per follicle aspirated.
During oocyte retrieval
Oocyte maturation rate
Time Frame: 2-3 hours post oocyte retrieval
Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised.
2-3 hours post oocyte retrieval
Fertilization rate
Time Frame: Day 1 post oocyte retrieval
Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised.
Day 1 post oocyte retrieval
Percentage of good quality blastocysts on day 5
Time Frame: 5 days post oocyte retrieval
Number of good quality blastocysts divided by the number of fertilized oocytes per ovary randomised.
5 days post oocyte retrieval
Average oocyte score
Time Frame: 2-3 hours post oocyte retrieval
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.
2-3 hours post oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eugonia

Collaborators

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: George T Lainas, PhD, Eugonia ART Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Flow rate for oocyte retrieval

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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