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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Eugonia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eugonia
ClinicalTrials.gov Identifier:
NCT00417183
First received: December 22, 2006
Last updated: December 28, 2006
Last verified: December 2006
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Arvekap 0.1 mg (Triptorelin, Ipsen, France)
Drug: Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation in Normal Responders

Resource links provided by NLM:


Further study details as provided by Eugonia:

Primary Outcome Measures:
  • Ongoing pregnancy per embryo transfer

Secondary Outcome Measures:
  • Biochemical pregnancy per embryo transfer
  • Clinical pregnancy per embryo transfer
  • Embryological data

Estimated Enrollment: 300
Study Start Date: September 2005
Estimated Study Completion Date: June 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417183

Contacts
Contact: Tryfon Lainas, PhD 00302107236333 ivf@eugonia.com.gr

Locations
Greece
Eugonia Recruiting
Athens, Greece, 11528
Contact: Tryfon Lainas, PhD    00302107236333    ivf@eugonia.com.gr   
Sponsors and Collaborators
Eugonia
Investigators
Principal Investigator: Tryfon Lainas, PhD Eugonia
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00417183     History of Changes
Other Study ID Numbers: long vs flexible
Study First Received: December 22, 2006
Last Updated: December 28, 2006
Health Authority: Greece: National Organization of Medicines

Keywords provided by Eugonia:
GnRH antagonist
GnRH agonist
Long protocol
Flexible

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Deslorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014