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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417066
• Other study ID #: poor responders
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2006
• Last updated: December 13, 2013
• Start date: September 2003
• Est. completion date: July 2006

Study information

• Verified date: January 2009
• Source: Eugonia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Menopause, Premature
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Drug:
• Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

• Arvekap 0.1mg (Triptorelin, Ipsen, France)

Locations

Country	Name	City	State
Greece	Eugonia	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate per embryo transfer
Secondary	Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.
Secondary	Number of mature oocytes retrieved.
Secondary	Number of fertilised oocytes.