Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders
|ClinicalTrials.gov Identifier: NCT00417066|
Recruitment Status : Completed
First Posted : December 29, 2006
Last Update Posted : December 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Infertility Premature Ovarian Failure||Drug: Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) Drug: Arvekap 0.1mg (Triptorelin, Ipsen, France)||Phase 4|
Poor responders are women who fail to respond effectively to the usual gonadotropin stimulation protocol applied in an IVF cycle. It seems that a diminished ovarian reserve is the principal factor of poor ovarian response. Several strategies have been proposed for the management of poor responders, including flare up GnRH agonist regimens and the GnRH antagonist, which presents a new hope in this group of patients.
Comparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or flare up agonist (Arvekap) protocol. Primary outcomes compared will be ongoing pregnancy rates in the two treatment groups.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||July 2006|
- Ongoing pregnancy rate per embryo transfer
- Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.
- Number of mature oocytes retrieved.
- Number of fertilised oocytes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417066
|Athens, Greece, 11528|
|Study Director:||Tryfon Lainas, PhD||Eugonia|