Heated and Non Heated Ovarian Aspiration Needle Protocol

Study Overview
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Brief Summary
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The success of IVF is influenced by factors as cause of infertility and age. Furthermore, there is a large influence of external factors, from the laboratory environment, handling and cultivation of gametes and embryos. The existence of factors capable of affecting the success of the treatment lead to the need of a quality control to attenuate the unfavorable effects. After ovarian stimulation, follicular aspiration is performed. At this moment, factors such as aspiration technique, needle type and temperature are the main variables to be controlled. It is known that oocytes are the more sensitive cells to temperature fluctuations. Currently, the standard protocol for follicular aspiration does not include the warming of the aspiration needle. However, due to the existing evidence in the literature, that the follicular fluid temperature drops during the aspiration procedure, this work aims to evaluate the influence of a pre warming of the aspiration needle as a new protocol.

Detailed Description
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The estimated sample was 600 oocytes for each group, totaling a minimum of 1200 oocytes, considering a fertilization rate of 65% in the control group and 73% in the study group, for a power of 80% and p alpha 5%, i.e. , an increase of more than 10% between groups. As there is no data in the literature, when the investigators have this sample an interim analysis to evaluate the data will be performed. The investigators consider 10% a reasonable difference that can (with this sample size) increase by 48 embryos and a possible increase of 7 pregnancies within this sample. Bearing in mind that the average number of oocytes retrieved per patient is 6 oocytes, the investigators estimate that 200 patients will be needed to reach the calculated sample number. The warm-up protocol will be applied by the embryologists, which consists of heating the follicular aspiration needle to 37 Celsius, overnight, the day before the day of the ovarian aspiration procedure. The variables that will be compared between the studied groups are the rates of oocyte retrieval, maturity (MII), fracture, atresia, fertilization rates and discarded embryos. Continuous variables will be analyzed using Student's t test if they have normal distribution, for comparison of means between two independent groups or the Wilcoxon-Mann-Whitney U test if not parametric. Differences between groups will be considered significant when p<0.05.

Official Title
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Randomized Clinical Trial in Women Submitted to in Vitro Fertilization: Warming Versus Not Warming of the Follicular Aspiration Needle.

Conditions
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Infertility, Female

Intervention / Treatment
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* Other: warming of the follicular aspiration needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women submitted to IVF cycles Exclusion Criteria: Women submitted to follicular aspiration due to oocyte cryopreservation Patients without oocyte retrieved Patients without mature oocyte retrieved Procedures with needle replacement
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard protocol<br>The standard protocol comprises no heating of the aspiration needle. | |
| Experimental: Warming protocol<br>The aspiration needle will be warm-up overnight the day before the oocyte pick-up procedure | Other: warming of the follicular aspiration needle<br>* the follicular aspiration needle will be heated overnight before the ovarian aspiration procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normal fertilization rate | Fertilization will be confirmed through the visualization of the presence of two pronuclei | 16 to 18 hours after fertilization procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocyte retrieved | the total number of oocytes captured in the ovarian aspiration procedure | immediately after ovarian aspiration procedure | 
| number of mature oocyte | total number of MII | 3 hours post ovarian aspiration | 
| oocyte damage rate | the number of fractured oocytes or atresia | 3 hours post ovarian aspiration | 
| abnormal fertilization rate | the total number of zygotes with three or more pronuclei | 16 to 18 hours after fertilization procedure |