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

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ClinicalTrials.gov Identifier: NCT00417066
Recruitment Status : Completed
First Posted : December 29, 2006
Last Update Posted : December 16, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
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
Study Start Date : September 2003
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Deslorelin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Ongoing pregnancy rate per embryo transfer

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

Eligibility Criteria

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
Criteria

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


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

Publications:
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 Posted: December 29, 2006    Key Record Dates
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:
Infertility
Primary Ovarian Insufficiency
Menopause, Premature
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Deslorelin
Triptorelin Pamoate
Ganirelix
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