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Completed

NCT Number: NCT06019494

Comparison of 2 Different Flow Rates During Oocyte Retrieval

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eugonia Unit of Assisted Reproduction

Athens, 11528, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: During oocyte retrieval

    Number of oocytes retrieved per ovary randomised.

Secondary outcomes

  1. Oocyte recovery rate

    Time frame: During oocyte retrieval

    Number of oocytes retrieved per follicle aspirated.

  2. Oocyte maturation rate

    Time frame: 2-3 hours post oocyte retrieval

    Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised.

  3. Average oocyte score

    Time frame: 2-3 hours post oocyte retrieval

    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.

  4. Fertilization rate

    Time frame: Day 1 post oocyte retrieval

    Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised.

  5. Percentage of good quality blastocysts on day 5

    Time frame: 5 days post oocyte retrieval

    Number of good quality blastocysts divided by the number of fertilized oocytes per ovary randomised.

Sponsors and collaborators

Lead sponsor

Eugonia

Other

Collaborators

  • Aristotle University Of Thessaloniki

Registry information

Official study title

Is Flow Rate During Oocyte Retrieval Associated With the Number of Oocytes Retrieved? A Randomized Control Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 31, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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