Clinical trial NCT06019494: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Flow rate
Aspiration pressure
Oocyte retrieval
Lead sponsor: Eugonia
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
First posted: 2023-08-31
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: During oocyte retrieval
Secondary outcomes:
measure: Oocyte recovery rate
timeFrame: During oocyte retrieval
measure: Oocyte maturation rate
timeFrame: 2-3 hours post oocyte retrieval
measure: Average oocyte score
timeFrame: 2-3 hours post oocyte retrieval
measure: Fertilization rate
timeFrame: Day 1 post oocyte retrieval
measure: Percentage of good quality blastocysts on day 5
timeFrame: 5 days post oocyte retrieval
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia Unit of Assisted Reproduction
Study officials:
affiliation: Eugonia ART Unit
name: George T Lainas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.