Comparison of 2 Different Flow Rates During Oocyte Retrieval

Study Overview
=================
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 <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 17G 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.

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Oocyte retrieval with low aspiration flow rate
* Procedure: Oocyte retrieval with high aspiration flow rate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of both ovaries 18-43 years old At least two follicles >14mm present in each ovary on day of triggering final oocyte maturation. Exclusion Criteria: One or no ovaries present Monofollicular development Poor responders Previous history of hemorrhage during oocyte retrieval

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low aspiration flow rate<br>All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.42ml/sec. | Procedure: Oocyte retrieval with low aspiration flow rate<br>* 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.<br>|
| Experimental: High aspiration flow rate<br>All follicles will be aspirated with the addition of follicular flushing if necessary with an aspiration flow rate of 0.62ml/sec. | Procedure: Oocyte retrieval with high aspiration flow rate<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved | Number of oocytes retrieved per ovary randomised. | During oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oocyte recovery rate | Number of oocytes retrieved per follicle aspirated. | During oocyte retrieval | 
| 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 | 
| 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 | 
| Fertilization rate | Number of fertilised (2PN) oocytes divided by the number of matured oocytes retrieved per ovary randomised. | Day 1 post oocyte retrieval | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flow rate, Aspiration pressure, Oocyte retrieval