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

This study has been completed.
Sponsor:
Information provided by:
Eugonia
ClinicalTrials.gov Identifier:
NCT00417066
First received: December 22, 2006
Last updated: December 13, 2013
Last verified: January 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
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: NCT00417066

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

Publications:
Additional 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
Study First Received: December 22, 2006
Last Updated: December 13, 2013
Health Authority: Greece: National Organization of Medicines

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

Additional relevant MeSH terms:
Infertility
Menopause, Premature
Primary Ovarian Insufficiency
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Deslorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014