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

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ClinicalTrials.gov Identifier: NCT01005784
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : November 2, 2009
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki

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

Condition or disease Intervention/treatment Phase
Subfertility Drug: Cetrorelix (Cetrotide) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fixed Versus Flexible GnRH Antagonist Initiation
Study Start Date : June 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Luteinizing hormone rise [ Time Frame: 3-14 days (duration of ovarian stimulation) ]


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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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

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): 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

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
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: November 2, 2009
Last Verified: October 2009

Keywords provided by Aristotle University Of Thessaloniki:
GnRH antagonists

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Cetrorelix
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists