Back to results

Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

Primary Purpose

Infertility, Premature Ovarian Failure

Status

Completed

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

Arvekap 0.1mg (Triptorelin, Ipsen, France)

About this trial

This is an interventional treatment trial for Infertility focused on measuring poor responders, GnRH antagonist, GnRH agonist, flare up, short protocol

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

regular menstrual cycle
1 or more failed IVF attempts with poor response
5 or fewer oocytes retrieved
FSH>12 IU/l on day 3

Exclusion Criteria:

PCOS
Normal responders

Sites / Locations

Eugonia

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate per embryo transfer

Secondary Outcome Measures

Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.

Number of mature oocytes retrieved.

Number of fertilised oocytes.

Full Information

NCT ID

NCT00417066

First Posted

December 22, 2006

Last Updated

December 13, 2013

Sponsor

Eugonia

1. Study Identification

Unique Protocol Identification Number

NCT00417066

Brief Title

Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

Official Title

The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eugonia

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes compared to the flare up protocol in this group of patients.

Detailed Description

Poor responders are women who fail to respond effectively to the usual gonadotropin stimulation protocol applied in an IVF cycle. It seems that a diminished ovarian reserve is the principal factor of poor ovarian response. Several strategies have been proposed for the management of poor responders, including flare up GnRH agonist regimens and the GnRH antagonist, which presents a new hope in this group of patients. Comparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or flare up agonist (Arvekap) protocol. Primary outcomes compared will be ongoing pregnancy rates in the two treatment groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Premature Ovarian Failure

Keywords

poor responders, GnRH antagonist, GnRH agonist, flare up, short protocol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

270 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

Intervention Type

Drug

Intervention Name(s)

Arvekap 0.1mg (Triptorelin, Ipsen, France)

Primary Outcome Measure Information:

Title

Ongoing pregnancy rate per embryo transfer

Secondary Outcome Measure Information:

Title

Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.

Title

Number of mature oocytes retrieved.

Title

Number of fertilised oocytes.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: regular menstrual cycle 1 or more failed IVF attempts with poor response 5 or fewer oocytes retrieved FSH>12 IU/l on day 3 Exclusion Criteria: PCOS Normal responders

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tryfon Lainas, PhD

Organizational Affiliation

Eugonia

Official's Role

Study Director

Facility Information:

Facility Name

Eugonia

City

Athens

ZIP/Postal Code

11528

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

12638782

Citation

Tarlatzis BC, Zepiridis L, Grimbizis G, Bontis J. Clinical management of low ovarian response to stimulation for IVF: a systematic review. Hum Reprod Update. 2003 Jan-Feb;9(1):61-76. doi: 10.1093/humupd/dmg007.

Results Reference

background

PubMed Identifier

18403419

Citation

Lainas TG, Sfontouris IA, Papanikolaou EG, Zorzovilis JZ, Petsas GK, Lainas GT, Kolibianakis EM. Flexible GnRH antagonist versus flare-up GnRH agonist protocol in poor responders treated by IVF: a randomized controlled trial. Hum Reprod. 2008 Jun;23(6):1355-8. doi: 10.1093/humrep/den107. Epub 2008 Apr 10.

Results Reference

derived

Learn more about this trial

Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders

We'll reach out to this number within 24 hrs