Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335569
Status:
COMPLETED
Last Update Posted:
2011-06-01
First Post:
2006-06-09
Brief Title:
Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation
Sponsor:
IBSA Institut Biochimique SA
Organization:
IBSA Institut Biochimique SA
Study Overview
Official Title:
A Prospective Randomized Controlled Clinical Study on the Assessment of Tolerance and Clinical Equivalence of hCG- IBSA IBSA Versus Ovitrelle Serono Both Administered Sub-cutaneously in Women Undergoing in Vitro Fertilization IVF
Status:
COMPLETED
Status Verified Date:
2011-05
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:
None
Brief Summary:
The purpose of the study is to evaluate the clinical equivalence and the general tolerability of two different subcutaneous hCG preparations hCG-IBSA IBSA vs Ovitrelle Serono when administered to patients undergoing IVF
Detailed Description:
This is a prospective multicenter randomized investigator blind parallel group active control phase III clinical trial Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug hCG-IBSA IBSA or the reference drug Ovitrelle Serono Investigators will be blinded by not allowing them to have any contact with the study medications supplied in boxes labeled in a manner that does not reveal the content of the boxes and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective
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