Comparison of 2 Different Flow Rates During Oocyte Retrieval

Eugonia

Status: Completed

Conditions: Infertility

Treatments: Procedure: Oocyte retrieval with high aspiration flow rate; Procedure: Oocyte retrieval with low aspiration flow rate

Study type: Interventional

Funder types: Other

Identifiers

NCT06019494

Flow rate for oocyte retrieval

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Low aspiration flow rate

Experimental group

Description:

All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec.

Treatment:

Procedure: Oocyte retrieval with low aspiration flow rate

High aspiration flow rate

Experimental group

Description:

All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec.

Treatment:

Procedure: Oocyte retrieval with high aspiration flow rate