Ignite Creation Date:
2024-05-06 @ 3:08 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02213627
Status:
UNKNOWN
Last Update Posted:
2015-07-17
First Post:
2014-08-08
Brief Title:
Use of Corifolitropin Alfa in Oocyte Donors
Sponsor:
IVI Madrid
Organization:
IVI Madrid
Study Overview
Official Title:
Randomized Multicentric and Prospective Clinical Trial to Check the Cost-effectiveness of Corifollitropin Alfa vs Recombinant FSH andor HP-hMG
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
RECRUITING
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 this study is to determine if corifollitropin alfa long-term gonadotropin administration is effective in a controlled ovarian stimulation protocol in oocyte donors compared to daily gonadotropin administration recombinant FSH or HP-hMG
Detailed Description:
In recent years increasingly advances have been developed in terms of controlled ovarian stimulation protocols These improvements have also moved into the way of administration of the different treatments and at present with subcutaneous devices it is possible to offer advantages such as the ability to ensure administration of the correct dose or modify the dose before charging
Simplification of ovarian stimulation protocols can help to reduce physical stress of the donors and the cancellation rate The need for daily injection does not worsen the degree of compliance but it generates some anxiety related to the administration of the right dose and or the possibility of making a unconsciously mistake Innovations in delivery devices could help reduce the stress associated with the stimulation itself and improve the welfare of the donor Given these considerations the need to develop a stimulation protocol that reduces the physical and emotional burden of reproduction treatment is established
Corifollitropin alfa molecule is a full-length recombinant FSH generating a sustained effect of stimulation a single subcutaneous injection of this drug is able to replace the first seven injections of any daily FSH preparation so finally the result would be an overall decrease in the number of injections needed for the whole cycle Pharmacological and pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple stimulation protocols and the need for fewer resources when monitoring the donor including fewer clinic visits
Simplification of ovarian stimulation protocols can help to reduce physical stress of the donors and the cancellation rate The need for daily injection does not worsen the degree of compliance but it generates some anxiety related to the administration of the right dose and or the possibility of making a unconsciously mistake Innovations in delivery devices could help reduce the stress associated with the stimulation itself and improve the welfare of the donor Given these considerations the need to develop a stimulation protocol that reduces the physical and emotional burden of reproduction treatment is established
Corifollitropin alfa molecule is a full-length recombinant FSH generating a sustained effect of stimulation a single subcutaneous injection of this drug is able to replace the first seven injections of any daily FSH preparation so finally the result would be an overall decrease in the number of injections needed for the whole cycle Pharmacological and pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple stimulation protocols and the need for fewer resources when monitoring the donor including fewer clinic visits
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