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Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Arvekap 0.1 mg (Triptorelin, Ipsen, France)
Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)
Sponsored by
Eugonia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring GnRH antagonist, GnRH agonist, Long protocol, Flexible

Eligibility Criteria

21 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-39 years
  • Body mass index 18-29 kg/m2
  • Menstrual cycle from 24-35 days
  • Normal basal FSH (<10 IU/ml)
  • Normal basal LH (<10 IU/ml)
  • Normal basal estradiol (<80 pg/ml)

Exclusion Criteria:

  • Poor responder patients
  • Polycystic ovaries

Sites / Locations

  • EugoniaRecruiting

Outcomes

Primary Outcome Measures

Ongoing pregnancy per embryo transfer

Secondary Outcome Measures

Biochemical pregnancy per embryo transfer
Clinical pregnancy per embryo transfer
Embryological data

Full Information

First Posted
December 22, 2006
Last Updated
December 28, 2006
Sponsor
Eugonia
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1. Study Identification

Unique Protocol Identification Number
NCT00417183
Brief Title
Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation
Official Title
Randomized Controlled Trial Comparing the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation in Normal Responders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eugonia

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of two controlled ovarian stimulation protocols, the GnRH agonist protocol, widely known as the "long" protocol, and the flexible GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile patients receiving IVF treatment.
Detailed Description
The formulation of controlled ovarian stimulation protocols is one of the primary reasons for the successful development of IVF. The "long" GnRH agonist protocol, also known as the gold standard, has been widely used with considerable success. More recently, on the other hand, GnRH antagonist provide a new promising approach for endogenous gonadotrophin suppression by blocking the GnRH receptor. There is conflicting data in the literature regarding the relative merits of the two ovarian stimulation protocols. COMPARISON: Pregnancy rates and embryological data will by assessed in IVF patients treated with either the "long" GnRH agonist (Arvekap) or the flexible GnRH antagonist (Ganirelix) protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
GnRH antagonist, GnRH agonist, Long protocol, Flexible

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Arvekap 0.1 mg (Triptorelin, Ipsen, France)
Intervention Type
Drug
Intervention Name(s)
Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)
Primary Outcome Measure Information:
Title
Ongoing pregnancy per embryo transfer
Secondary Outcome Measure Information:
Title
Biochemical pregnancy per embryo transfer
Title
Clinical pregnancy per embryo transfer
Title
Embryological data

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-39 years Body mass index 18-29 kg/m2 Menstrual cycle from 24-35 days Normal basal FSH (<10 IU/ml) Normal basal LH (<10 IU/ml) Normal basal estradiol (<80 pg/ml) Exclusion Criteria: Poor responder patients Polycystic ovaries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tryfon Lainas, PhD
Phone
00302107236333
Email
ivf@eugonia.com.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tryfon Lainas, PhD
Organizational Affiliation
Eugonia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eugonia
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tryfon Lainas, PhD
Phone
00302107236333
Email
ivf@eugonia.com.gr

12. IPD Sharing Statement

Citations:
PubMed Identifier
15946995
Citation
Lainas T, Zorzovilis J, Petsas G, Stavropoulou G, Cazlaris H, Daskalaki V, Lainas G, Alexopoulou E. In a flexible antagonist protocol, earlier, criteria-based initiation of GnRH antagonist is associated with increased pregnancy rates in IVF. Hum Reprod. 2005 Sep;20(9):2426-33. doi: 10.1093/humrep/dei106. Epub 2005 Jun 9.
Results Reference
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Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation

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