search
Back to results

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

Primary Purpose

Subfertility

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Cetrorelix (Cetrotide)
Cetrorelix (Cetrotide)
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfertility focused on measuring GnRH antagonists

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • PCOS
  • Endometriosis

Sites / Locations

  • Unit for Human Reproduction

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

fixed

flexible

Arm Description

Outcomes

Primary Outcome Measures

Luteinizing hormone rise

Secondary Outcome Measures

Full Information

First Posted
November 13, 2007
Last Updated
October 30, 2009
Sponsor
Aristotle University Of Thessaloniki
search

1. Study Identification

Unique Protocol Identification Number
NCT01005784
Brief Title
Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation
Official Title
Fixed Versus Flexible GnRH Antagonist Initiation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
GnRH antagonists

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fixed
Arm Type
Active Comparator
Arm Title
flexible
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cetrorelix (Cetrotide)
Other Intervention Name(s)
Cetrorelix, Cetrotide, Serono
Intervention Description
flexible antagonist administration according to specified criteria
Intervention Type
Drug
Intervention Name(s)
Cetrorelix (Cetrotide)
Other Intervention Name(s)
Cetrorelix, Cetrotide, Serono
Intervention Description
fixed antagonist administration on day 6 of ovarian stimulation
Primary Outcome Measure Information:
Title
Luteinizing hormone rise
Time Frame
3-14 days (duration of ovarian stimulation)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: < 39 years of age BMI 18.5-29.9 <= 3 previous IVF cycles Exclusion Criteria: PCOS Endometriosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efstratios Kolibianakis
Organizational Affiliation
Unit for Human Reproduction
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit for Human Reproduction
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
20637457
Citation
Kolibianakis EM, Venetis CA, Kalogeropoulou L, Papanikolaou E, Tarlatzis BC. Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial. Fertil Steril. 2011 Feb;95(2):558-62. doi: 10.1016/j.fertnstert.2010.05.052. Epub 2010 Jul 16.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs