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| Name | Class |
|---|---|
| Aristotle University Of Thessaloniki | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oocyte retrieval with low aspiration flow rate | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | Number of oocytes retrieved per ovary randomised. | During oocyte retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| Oocyte recovery rate | Number of oocytes retrieved per follicle aspirated. | During oocyte retrieval |
| Oocyte maturation rate | Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised. |
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Inclusion Criteria:
Exclusion Criteria:
Participants must have both ovaries present
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| Name | Affiliation | Role |
|---|---|---|
| George T Lainas, PhD | Eugonia ART Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eugonia Unit of Assisted Reproduction | Athens | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26630267 | Background | 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. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D054315 | Oocyte Retrieval |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D020858 | Tissue and Organ Harvesting |
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| Oocyte retrieval with high aspiration flow rate | Procedure | 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. |
|
| 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. | 2-3 hours post oocyte retrieval |
| Fertilization rate | 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 | Number of good quality blastocysts divided by the number of fertilized oocytes per ovary randomised. | 5 days post oocyte retrieval |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |