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
  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:


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
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: 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:
Cetrorelix
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014