Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05683639 |
| Other study ID # |
60504522.7.0000.5327 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2023 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Hospital de Clinicas de Porto Alegre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
