Ignite Creation Date:
2024-05-06 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03483545
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2018-03-08
Brief Title:
Menopur And Rekovelle Combination Study
Sponsor:
Dr François Bissonnette
Organization:
Clinique Ovo
Study Overview
Official Title:
An Exploratory Study to Evaluate a Mixed Protocol of Menopur Highly Purified Human Menopausal Gonadotropin and REKOVELLE Follitropin Delta for Controlled Ovarian Stimulation in IVF in Vitro Fertilization
Status:
COMPLETED
Status Verified Date:
2019-08
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:
MARCS
Brief Summary:
This study proposes to evaluate the effect of adding HP-hMG Menopur to follitropin delta in a mixed protocol regimen using an individualized fixed dose of follitropin delta based on the established algorithm combined with a variable adjustable dose of Menopur based on body weight and ovarian reserve
Detailed Description:
The initial dose of follitropin delta will be determined at enrolment by the analysis of serum AMH on days 2 to 5 of the menstrual cycle preceding the IVF treatment cycle and body weight in Kg The initial dose of HP-hMG to be added on top of follitropin delta will be determined at enrolment by the total follitropin delta dose and body weight in Kg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None