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

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ClinicalTrials.gov Identifier: NCT00417183
Recruitment Status : Unknown
Verified December 2006 by Eugonia.
Recruitment status was:  Recruiting
First Posted : December 29, 2006
Last Update Posted : December 29, 2006
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Drug: Arvekap 0.1 mg (Triptorelin, Ipsen, France) Drug: Ganirelix 0.25 (Orgalutran, Organon, The Netherlands) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2005
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Deslorelin
U.S. FDA Resources

Primary Outcome Measures :
  1. Ongoing pregnancy per embryo transfer

Secondary Outcome Measures :
  1. Biochemical pregnancy per embryo transfer
  2. Clinical pregnancy per embryo transfer
  3. Embryological data

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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): NCT00417183

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

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

ClinicalTrials.gov Identifier: NCT00417183     History of Changes
Other Study ID Numbers: long vs flexible
First Posted: December 29, 2006    Key Record Dates
Last Update Posted: December 29, 2006
Last Verified: December 2006

Keywords provided by Eugonia:
GnRH antagonist
GnRH agonist
Long protocol

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Triptorelin Pamoate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists