Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01816321
Status:
COMPLETED
Last Update Posted:
2016-06-23
First Post:
2013-03-16
Brief Title:
Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial
Sponsor:
Universitair Ziekenhuis Brussel
Organization:
Universitair Ziekenhuis Brussel
Study Overview
Official Title:
Corifollitropin Alfa Followed by Hp-HMG Versus Recombinant FSH in Young Poor Ovarian Responders A Multicentre Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2016-06
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:
COMPORT
Brief Summary:
In combination with the existing literature previous work indicates that 1 women with poor ovarian response fulfilling the Bologna criteria have very low pregnancy rates irrespective of age 2 current treatment protocols demonstrate ongoing pregnancy rates that do not exceed 85 and 3 corifollitropin alfa followed by hpHMG might increase ongoing pregnancy rates in young patients 40years old fulfilling the criteria These findings provide a strong rationale for a definitive large RCT The COMPORT study will provide conclusive evidence regarding the superiority or not of this novel protocol with corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders fulfilling the Bologna criteria
Detailed Description:
Recently the European Society of Human Reproduction and Embryology developed a new definition in order to select patients suitable for inclusion in future clinical trials as poor ovarian responders the so-called Bologna criteria However a limited number of studies has been published to date including patients with poor ovarian response according to the Bologna criteria whereas no randomized trial is published or ongoing for this population
Preliminary reports in Bologna poor responders highlight the limited prospects for these women Natural cycle IVF has been shown to result in disappointingly low live birth rates regardless of patients age and ovarian stimulation with widely accepted treatment modalities eg short agonist protocol did not appear demonstrate substantial benefits
Nonetheless despite the disappointing results from the vast majority of the preliminary studies in this population a recent pilot study by our group has shown that a specific protocol may indeed be a promising option for women of younger age fulfilling the Bologna criteria Corifollitropin alfa followed by highly purified hMG in an antagonist protocol demonstrated an ongoing pregnancy rate of 28 in women 40years strongly suggesting the conduction of a future randomized trial testing this novel treatment protocol
Preliminary reports in Bologna poor responders highlight the limited prospects for these women Natural cycle IVF has been shown to result in disappointingly low live birth rates regardless of patients age and ovarian stimulation with widely accepted treatment modalities eg short agonist protocol did not appear demonstrate substantial benefits
Nonetheless despite the disappointing results from the vast majority of the preliminary studies in this population a recent pilot study by our group has shown that a specific protocol may indeed be a promising option for women of younger age fulfilling the Bologna criteria Corifollitropin alfa followed by highly purified hMG in an antagonist protocol demonstrated an ongoing pregnancy rate of 28 in women 40years strongly suggesting the conduction of a future randomized trial testing this novel treatment protocol
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-000583-29 | EUDRACT_NUMBER | None | None |