Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01816789
Status:
TERMINATED
Last Update Posted:
2016-12-23
First Post:
2013-03-20
Brief Title:
Age Versus Ovarian Reserve Markers Based Therapy in IVF IVFIntracytoplasmic Sperm Injection ICSI Cycles
Sponsor:
Andros Day Surgery Clinic
Organization:
Andros Day Surgery Clinic
Study Overview
Official Title:
Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Optimal response 63 nomogram 42 controls overcoming the stopping rule for interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized controlled trial has been designed for carrying out a comparison of new AMH Anti-Müllerian Hormone-based individualized treatment using a nomogram with the wide accepted age-based strategy The main objective of the trial is to assess whether an individualized FSH starting dose can increase the rate of women with an adequate ovarian response in terms of retrieved oocytes optimal number of retrieved oocytes 8-14
Detailed Description:
Before clinicians can adopt any model into routine clinical practice the accuracy of the model should be independently evaluated in a population different from the one on which the model was elaborated External validation of the model is therefore crucial to assess the generalizability to other populations
In the present RCT the new AMH-based individualized treatment will be compared to the wide accepted age-based strategy
Primary endpoint
The percentage of women with an appropriate number n8-14 of retrieved oocytes in IVFICSI cycle
Secondary endpoints
1 Serum E2 levels on r-hCG day
2 Serum P levels on r-hCG day
3 Number of growing follicles 11mm on r-hCG day
4 Number of large 17 mm ovarian follicles on r-hCG day
5 Total r-FSH dose employed
6 Treatment duration
7 Rate of women with dose adjustment
8 Number of cancelled cycles because of poor and hyper-response
9 Fertilization rate
10 Embryos obtained
11 Implantation rates
12 Biochemical pregnancy rates
13 Clinical pregnancy rates
14 OHSS rates
In the present RCT the new AMH-based individualized treatment will be compared to the wide accepted age-based strategy
Primary endpoint
The percentage of women with an appropriate number n8-14 of retrieved oocytes in IVFICSI cycle
Secondary endpoints
1 Serum E2 levels on r-hCG day
2 Serum P levels on r-hCG day
3 Number of growing follicles 11mm on r-hCG day
4 Number of large 17 mm ovarian follicles on r-hCG day
5 Total r-FSH dose employed
6 Treatment duration
7 Rate of women with dose adjustment
8 Number of cancelled cycles because of poor and hyper-response
9 Fertilization rate
10 Embryos obtained
11 Implantation rates
12 Biochemical pregnancy rates
13 Clinical pregnancy rates
14 OHSS rates
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