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Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 29, 2006
Last Update Posted: December 16, 2013
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:
The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes compared to the flare up protocol in this group of patients.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders

Resource links provided by NLM:

Further study details as provided by Eugonia:

Primary Outcome Measures:
  • Ongoing pregnancy rate per embryo transfer

Secondary Outcome Measures:
  • Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.
  • Number of mature oocytes retrieved.
  • Number of fertilised oocytes.

Estimated Enrollment: 270
Study Start Date: September 2003
Study Completion Date: July 2006
Detailed Description:

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • regular menstrual cycle
  • 1 or more failed IVF attempts with poor response
  • 5 or fewer oocytes retrieved
  • FSH>12 IU/l on day 3

Exclusion Criteria:

  • PCOS
  • Normal responders
  Contacts and Locations
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): NCT00417066

Athens, Greece, 11528
Sponsors and Collaborators
Study Director: Tryfon Lainas, PhD Eugonia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00417066     History of Changes
Other Study ID Numbers: poor responders
First Submitted: December 22, 2006
First Posted: December 29, 2006
Last Update Posted: December 16, 2013
Last Verified: January 2009

Keywords provided by Eugonia:
poor responders
GnRH antagonist
GnRH agonist
flare up
short protocol

Additional relevant MeSH terms:
Primary Ovarian Insufficiency
Menopause, Premature
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
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