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Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation

This study has been completed.
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01005784
First received: November 13, 2007
Last updated: October 30, 2009
Last verified: October 2009
History of Changes
  Purpose

This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.


Condition Intervention Phase
Subfertility
 Drug: Cetrorelix (Cetrotide)
 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: Fixed Versus Flexible GnRH Antagonist Initiation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • Luteinizing hormone rise [ Time Frame: 3-14 days (duration of ovarian stimulation) ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: June 2005
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fixed Drug: Cetrorelix (Cetrotide)
fixed antagonist administration on day 6 of ovarian stimulation
Other Name: Cetrorelix, Cetrotide, Serono
Experimental: flexible Drug: Cetrorelix (Cetrotide)
flexible antagonist administration according to specified criteria
Other Name: Cetrorelix, Cetrotide, Serono

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • < 39 years of age
  • BMI 18.5-29.9
  • <= 3 previous IVF cycles

Exclusion Criteria:

  • PCOS
  • Endometriosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005784

Locations
Greece
Unit for Human Reproduction
Thessaloniki, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
Principal Investigator: Efstratios Kolibianakis Unit for Human Reproduction
  More Information

No publications provided by Aristotle University Of Thessaloniki

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Basil Tarlatzis, Medical School, Aristotle University of Thessaloniki
ClinicalTrials.gov Identifier: NCT01005784     History of Changes
Other Study ID Numbers: UHR-3
Study First Received: November 13, 2007
Last Updated: October 30, 2009
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Aristotle University Of Thessaloniki:
GnRH antagonists

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Cetrorelix
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013