InfertilityNCT06019494
Comparison of 2 Different Flow Rates During Oocyte Retrieval
A study testing Oocyte retrieval with low aspiration flow rate and Oocyte retrieval with high aspiration flow rate in people with Infertility, run by Eugonia at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Oocyte retrieval with low aspiration flow rate and Oocyte retrieval with high aspiration flow rate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Presence of both ovaries
- 18-43 years old
- At least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval
Who cannot join
- One or no ovaries present
- Monofollicular development
- Poor responders
- Previous history of hemorrhage during oocyte retrieval
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Oocyte retrieval with low aspiration flow rate, Oocyte retrieval with high aspiration flow rate
- Keywords
- Flow rate, Aspiration pressure, Oocyte retrieval
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte retrieval with low aspiration flow rateProcedure or surgery
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.
Oocyte retrieval with high aspiration flow rateProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Low aspiration flow rate | Experimental | All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec. Receives: Procedure: Oocyte retrieval with low aspiration flow rate |
| High aspiration flow rate | Experimental | All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec. Receives: Procedure: Oocyte retrieval with high aspiration flow rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Number of oocytes retrieved per ovary randomised.
Measured: During oocyte retrieval
Secondary outcomes (5)
Oocyte recovery rate
Number of oocytes retrieved per follicle aspirated.
Measured: During oocyte retrieval
Oocyte maturation rate
Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised.
Measured: 2-3 hours post oocyte retrieval
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.
Measured: 2-3 hours post oocyte retrieval
Fertilization rate
Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised.
Measured: Day 1 post oocyte retrieval
Percentage of good quality blastocysts on day 5
Number of good quality blastocysts divided by the number of fertilized oocytes per ovary randomised.
Measured: 5 days post oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Sep 2023
- Primary completion30 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eugonia
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Responsible party
- Sponsor
- Investigators
- George T Lainas, PhD, Principal investigator, Eugonia ART Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019494
- Sponsor's protocol ID
- Flow rate for oocyte retrieval
- Status last verified
- Feb 2024
- First submitted
- 8 Aug 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26630267
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Flow Rate During Oocyte Retrieval Associated With the Number of Oocytes Retrieved? A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06019494
- Acronym / sponsor ID
- Flow rate for oocyte retrieval
- Conditions
- Infertility
- Keywords
- Flow rate, Aspiration pressure, Oocyte retrieval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- EugoniaUniversity, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low aspiration flow rate | Experimental | Procedure: Oocyte retrieval with low aspiration flow rateAll follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec. |
| High aspiration flow rate | Experimental | Procedure: Oocyte retrieval with high aspiration flow rateAll follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of both ovaries
- 18-43 years old
- At least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval
Key exclusion criteria (4 listed)
- One or no ovaries present
- Monofollicular development
- Poor responders
- Previous history of hemorrhage during oocyte retrieval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oocyte retrieval with low aspiration flow rateAll 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. | Procedure or surgery | Low aspiration flow rate |
| Oocyte retrieval with high aspiration flow rateHigh 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. | Procedure or surgery | High aspiration flow rate |
Primary outcome
Number of oocytes retrieved
Time frame: During oocyte retrieval
Number of oocytes retrieved per ovary randomised.
5 secondary outcomes
Oocyte recovery rate
Time frame: During oocyte retrieval
Oocyte maturation rate
Time frame: 2-3 hours post oocyte retrieval
Average oocyte score
Time frame: 2-3 hours post oocyte retrieval
Fertilization rate
Time frame: Day 1 post oocyte retrieval
Percentage of good quality blastocysts on day 5
Time frame: 5 days post oocyte retrieval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 26630267Lazzaroni-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George T Lainas, PhD principal investigator
Eugonia ART Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocyte retrieval with low aspiration flow rate and Oocyte retrieval with high aspiration flow rate in people with Infertility, run by Eugonia at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocytes retrieved (time frame: During oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.