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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00417066
Enrollment
270
Registered
2006-12-29
Start date
2003-09-30
Completion date
2006-07-31
Last updated
2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Premature Ovarian Failure

Keywords

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

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.

Interventions

Sponsors

Eugonia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Ongoing pregnancy rate per embryo transfer

Secondary

MeasureTime frame
Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.
Number of mature oocytes retrieved.
Number of fertilised oocytes.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026