Ignite Creation Date:
2025-12-18 @ 8:27 AM
Ignite Modification Date:
2025-12-18 @ 8:27 AM
Study NCT ID:
NCT05676515
Status:
None
Last Update Posted:
2024-02-28 00:00:00
First Post:
2022-12-22 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Different Culture Media for in Vitro Fertilization
Sponsor:
None
Organization:
Study Overview
Official Title:
Evaluation of Different Culture Media for in Vitro Fertilization: a Randomized Clinical Trial
Status:
None
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For this prospective randomized clinical trial, patients undergoing IVF cycles with at least three oocytes obtained from ovarian aspiration procedure will be enrolled. Considering a 30% difference between the groups in the number of good quality embryos (A + B) with power of 80% and p alpha 5%, the n calculated was 95 oocytes for each group, totaling 285 oocytes retrieved and 48 patients, as the mean number of oocytes per patient is 6.
The two main parameters that will be evaluated are:
Fertilization rate: An oocyte with 2 pronuclei and 2 polar bodies formed (2PN/2CPs) is considered fertilized. The evaluation of oocyte fertilization rates in three tested media will be measured by the percentage of 2PN/2CPs zygotes observed in the check between 16-18 hours after fertilization by IVF or ICSI.
Embryo quality: Embryos will be classified as A, B, C or D according to the scheme below, with A and B embryos being considered good quality embryos. The evaluation of embryonic quality will be carried out on the third day (64-67 hours after fertilization) taking into account the parameters of cell number, symmetry and fragmentation.
Embryo quality was defined as the primary outcome of this study because it is a parameter directly related to the prognosis of in vitro fertilization treatment, and it has a predefined value in the Vienna consensus being commonly described in scientific articles.
Fertilization rates and good quality embryos will be expressed as percentages (mean and standard deviation). The chi-square test will be used to compare fertilization and embryonic quality between the culture media and the difference will be considered significant if p \< 0.05. For tabulation and statistical analysis, the JASP software version 0.16.2 will be used.
The two main parameters that will be evaluated are:
Fertilization rate: An oocyte with 2 pronuclei and 2 polar bodies formed (2PN/2CPs) is considered fertilized. The evaluation of oocyte fertilization rates in three tested media will be measured by the percentage of 2PN/2CPs zygotes observed in the check between 16-18 hours after fertilization by IVF or ICSI.
Embryo quality: Embryos will be classified as A, B, C or D according to the scheme below, with A and B embryos being considered good quality embryos. The evaluation of embryonic quality will be carried out on the third day (64-67 hours after fertilization) taking into account the parameters of cell number, symmetry and fragmentation.
Embryo quality was defined as the primary outcome of this study because it is a parameter directly related to the prognosis of in vitro fertilization treatment, and it has a predefined value in the Vienna consensus being commonly described in scientific articles.
Fertilization rates and good quality embryos will be expressed as percentages (mean and standard deviation). The chi-square test will be used to compare fertilization and embryonic quality between the culture media and the difference will be considered significant if p \< 0.05. For tabulation and statistical analysis, the JASP software version 0.16.2 will be used.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: