Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335725
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2006-06-09
Brief Title:
Efficacy and Tolerability of Human FSH Versus Recombinant FSH Follitropin Alpha in ICSI
Sponsor:
IBSA Institut Biochimique SA
Organization:
IBSA Institut Biochimique SA
Study Overview
Official Title:
Multicentric Prospective Randomised Controlled Clinical Study on Clinical Efficacy and Tolerability of Urinary FSH Fostimon IBSA Versus r-FSH Gonal-F Serono in ICSI
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations Fostimon IBSA Vs Gonal-F Serono when administered in patients undergoing ICSI
Detailed Description:
This is a multicentric prospective randomised investigator blind controlled clinical trial phase III of two parallel groups one receiving the test drug FSH Fostimon IBSA and the other the reference drug FSH Gonal-F Serono The groups will be paired on the major prognostic criteria
In effect a double blind trial is not really feasible since the drugs presentations are very different However in IVF drugs are usually dispensed andor injected by a nurse and therefor the Investigator can be blind Moreover the used preparations will contain the same amount of gonadotrophin units 75 IU will be repackaged in anonymous boxes and the following sentence will be written in the Patient Information Sheet You are required not to inform the Investigator about the products name
The randomisation is necessary to get groups as comparable as possible for all the other aspects The multicentric design has the double interest of facilitating the patients recruitment and of decreasing the biases related to attitudes in a specific centre
In effect a double blind trial is not really feasible since the drugs presentations are very different However in IVF drugs are usually dispensed andor injected by a nurse and therefor the Investigator can be blind Moreover the used preparations will contain the same amount of gonadotrophin units 75 IU will be repackaged in anonymous boxes and the following sentence will be written in the Patient Information Sheet You are required not to inform the Investigator about the products name
The randomisation is necessary to get groups as comparable as possible for all the other aspects The multicentric design has the double interest of facilitating the patients recruitment and of decreasing the biases related to attitudes in a specific centre
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