Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
BEst Size for Ovulation Triggering in Poseidon 4 Patients BEST 4 Study
Sponsor:
Centrum Clinic IVF Center
Organization:
Centrum Clinic IVF Center
Study Overview
Official Title:
What Should Be The Optimal Ovulation Triggering Size in Poseidon Group 4 Patients Undergoing Ovarian Stimulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
BEST
Brief Summary:
This observational clinical study aims to determine the optimal timing of ovulation triggering in women aged 35 and above with poor ovarian reserve
For this purpose cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups
1 Experimental Group Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm
2 Control Group Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm
All triggers will be administered uniformly with 6500 units of recombinant hCG and 02 mg triptorelin injections
The primary outcome of the study will be the number of mature oocytes Secondary outcomes will include fertilization rates embryo counts and implantation rates
Primary and secondary outcomes will be compared between the two groups
For this purpose cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups
1 Experimental Group Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm
2 Control Group Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm
All triggers will be administered uniformly with 6500 units of recombinant hCG and 02 mg triptorelin injections
The primary outcome of the study will be the number of mature oocytes Secondary outcomes will include fertilization rates embryo counts and implantation rates
Primary and secondary outcomes will be compared between the two groups
Detailed Description:
The timing of final oocyte maturation in assisted reproductive techniques is critically important If serum steroid hormone levels are appropriate during the late follicular phase ovulation triggering can be performed using various agents There are numerous comparative studies in the literature on this topic
However a key issue is determining the most optimal timing for this trigger In standard practice the final triggering is performed when the follicle size reaches 17 mm or more
The purpose of this is to obtain mature eggs from these follicles during the oocyte aspiration process
However in some special cases to maximize the desired yield this size threshold may be adjusted
A prime example of this is in older patients with poor ovarian reserve as the expected egg yield may not be achieved with standard practices
During the oocyte collection process fewer mature oocytes M2 may be retrieved or no oocytes may be retrieved at all despite proper ovarian stimulation Therefore the optimal follicle size for these cases has not been definitively established in the literature Thus there is a need to determine other follicular thresholds specifically for older women with poor ovarian reserves to enhance egg and mature egg yields
For this purpose cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups
1 Experimental Group Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm
2 Control Group Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm
All triggers will be administered uniformly with 6500 units of recombinant hCG and 02 mg triptorelin injections
The primary outcome of the study will be the number of mature oocytes Secondary outcomes will include fertilization rates embryo counts and implantation rates
Primary and secondary outcomes will be compared between the two groups
However a key issue is determining the most optimal timing for this trigger In standard practice the final triggering is performed when the follicle size reaches 17 mm or more
The purpose of this is to obtain mature eggs from these follicles during the oocyte aspiration process
However in some special cases to maximize the desired yield this size threshold may be adjusted
A prime example of this is in older patients with poor ovarian reserve as the expected egg yield may not be achieved with standard practices
During the oocyte collection process fewer mature oocytes M2 may be retrieved or no oocytes may be retrieved at all despite proper ovarian stimulation Therefore the optimal follicle size for these cases has not been definitively established in the literature Thus there is a need to determine other follicular thresholds specifically for older women with poor ovarian reserves to enhance egg and mature egg yields
For this purpose cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups
1 Experimental Group Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm
2 Control Group Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm
All triggers will be administered uniformly with 6500 units of recombinant hCG and 02 mg triptorelin injections
The primary outcome of the study will be the number of mature oocytes Secondary outcomes will include fertilization rates embryo counts and implantation rates
Primary and secondary outcomes will be compared between the two groups
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?:
None