Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00417144|
Recruitment Status : Unknown
Verified December 2006 by Eugonia.
Recruitment status was: Recruiting
First Posted : December 29, 2006
Last Update Posted : December 29, 2006
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Ovarian Hyperstimulation Syndrome||Drug: Arvekap 0.1mg (Triptorelin, Ipsen, France) Drug: Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients|
|Study Start Date :||November 2003|
|Study Completion Date :||May 2007|
- Development of OHSS
- Ongoing pregnancy rate per embryo transfer
- Biochemical pregnancy
- Clinical pregnancy
- Embryological data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417144
|Contact: Tryfon Lainas, PhDfirstname.lastname@example.org|
|Athens, Greece, 11528|
|Contact: Tryfon Lainas, PhD 00302107236333 email@example.com|
|Principal Investigator:||Tryfon Lainas, PhD||Eugonia|