Comparison of 2 Different Flow Rates During Oocyte Retrieval

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06019494
• Other study ID #: Flow rate for oocyte retrieval
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Eugonia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 31, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Oocyte retrieval with low 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 0.42 ml/sec.
• Oocyte retrieval with high aspiration flow rate
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.

Locations

Country	Name	City	State
Greece	Eugonia Unit of Assisted Reproduction	Athens

Sponsors (2)

Lead Sponsor	Collaborator
Eugonia	Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved	Number of oocytes retrieved per ovary randomised.	During oocyte retrieval
Secondary	Oocyte recovery rate	Number of oocytes retrieved per follicle aspirated.	During oocyte retrieval
Secondary	Oocyte maturation rate	Number of mature (metaphase-II) oocytes divided by the number of oocytes retrieved per ovary randomised.	2-3 hours post oocyte retrieval
Secondary	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
Secondary	Fertilization rate	Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised.	Day 1 post oocyte retrieval
Secondary	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