Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417144
Status:
UNKNOWN
Last Update Posted:
2006-12-29
First Post:
2006-12-22
Brief Title:
Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients
Sponsor:
Eugonia
Organization:
Eugonia
Study Overview
Official Title:
Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients
Status:
UNKNOWN
Status Verified Date:
2006-12
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 compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol
Detailed Description:
Women with polycystic ovarian syndrome PCOS represent a group of patients at high risk of developing ovarian hyperstimulation syndrome OHSS an iatrogenic complication of ovarian stimulation during IVF treatment In contrast to mild OHSS severe OHSS is a life-threatening complication characterized by massive ovarian enlargement ascites pleural effusion oliguria haemoconcentration and thromboembolic phenomena Currently no curative therapy for OHSS is available and thus prevention is considered the most effective treatment Several measures have been adopted to reduce the occurrence of the syndrome the most effective being cycle cancellation and withholding of human chorionic gonadotropin hCG which seems to be the most critical factor for the development of OHSS
COMPARISON This study aims to compare the development and severity of OHSS as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist Ganirelix protocol vs a long GnRH agonist Arvekap protocol of ovarian stimulation
COMPARISON This study aims to compare the development and severity of OHSS as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist Ganirelix protocol vs a long GnRH agonist Arvekap protocol of ovarian stimulation
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