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Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Eugonia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00417183
First Posted: December 29, 2006
Last Update Posted: December 29, 2006
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.
Information provided by:
Eugonia
December 22, 2006
December 29, 2006
December 29, 2006
September 2005
Not Provided
Ongoing pregnancy per embryo transfer
Same as current
No Changes Posted
  • Biochemical pregnancy per embryo transfer
  • Clinical pregnancy per embryo transfer
  • Embryological data
Same as current
Not Provided
Not Provided
 
Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation
Randomized Controlled Trial Comparing the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation in Normal Responders
The purpose of this study is to compare the efficacy of two controlled ovarian stimulation protocols, the GnRH agonist protocol, widely known as the "long" protocol, and the flexible GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile patients receiving IVF treatment.

The formulation of controlled ovarian stimulation protocols is one of the primary reasons for the successful development of IVF. The "long" GnRH agonist protocol, also known as the gold standard, has been widely used with considerable success. More recently, on the other hand, GnRH antagonist provide a new promising approach for endogenous gonadotrophin suppression by blocking the GnRH receptor. There is conflicting data in the literature regarding the relative merits of the two ovarian stimulation protocols.

COMPARISON: Pregnancy rates and embryological data will by assessed in IVF patients treated with either the "long" GnRH agonist (Arvekap) or the flexible GnRH antagonist (Ganirelix) protocol.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Infertility
  • Drug: Arvekap 0.1 mg (Triptorelin, Ipsen, France)
  • Drug: Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)
Not Provided
Lainas T, Zorzovilis J, Petsas G, Stavropoulou G, Cazlaris H, Daskalaki V, Lainas G, Alexopoulou E. In a flexible antagonist protocol, earlier, criteria-based initiation of GnRH antagonist is associated with increased pregnancy rates in IVF. Hum Reprod. 2005 Sep;20(9):2426-33. Epub 2005 Jun 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
300
June 2007
Not Provided

Inclusion Criteria:

  • Age 18-39 years
  • Body mass index 18-29 kg/m2
  • Menstrual cycle from 24-35 days
  • Normal basal FSH (<10 IU/ml)
  • Normal basal LH (<10 IU/ml)
  • Normal basal estradiol (<80 pg/ml)

Exclusion Criteria:

  • Poor responder patients
  • Polycystic ovaries
Sexes Eligible for Study: Female
21 Years to 39 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT00417183
long vs flexible
Not Provided
Not Provided
Not Provided
Not Provided
Eugonia
Not Provided
Principal Investigator: Tryfon Lainas, PhD Eugonia
Eugonia
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP