Comparison of 2 Different Flow Rates During Oocyte Retrieval

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Oocyte retrieval with low aspiration flow rate; Procedure: Oocyte retrieval with high aspiration flow rate

• Registration Number: NCT06019494
• Lead Sponsor: Eugonia

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.

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-31
• Study Start: 2023-09-01
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low aspiration flow rate	Oocyte retrieval with 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.
High aspiration flow rate	Oocyte retrieval with 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.

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	During oocyte retrieval	Number of oocytes retrieved per ovary randomised.

Secondary Outcome Measures

Name	Time	Method
Oocyte recovery rate	During oocyte retrieval	Number of oocytes retrieved per follicle aspirated.
Average oocyte score	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.
Oocyte maturation rate	2-3 hours post oocyte retrieval	Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised.
Fertilization rate	Day 1 post oocyte retrieval	Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised.
Percentage of good quality blastocysts on day 5	5 days post oocyte retrieval	Number of good quality blastocysts divided by the number of fertilized oocytes per ovary randomised.

Trial Locations

Locations (1)

Eugonia Unit of Assisted Reproduction; 🇬🇷 Athens, Greece