Comparison of 2 Different Flow Rates During Oocyte Retrieval
NCT ID: NCT06019494
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2023-09-01
2024-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 18-43 years old
* At least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval
Exclusion Criteria
* Monofollicular development
* Poor responders
* Previous history of hemorrhage during oocyte retrieval
18 Years
43 Years
FEMALE
Yes
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Eugonia
OTHER
Responsible Party
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Principal Investigators
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George T Lainas, PhD
Role: PRINCIPAL_INVESTIGATOR
Eugonia ART Unit
Locations
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Eugonia Unit of Assisted Reproduction
Athens, , Greece
Countries
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References
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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.
Other Identifiers
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Flow rate for oocyte retrieval
Identifier Type: -
Identifier Source: org_study_id
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