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

E

Eugonia

Status and phase

Completed
Phase 4

Conditions

Infertility
Premature Ovarian Failure

Treatments

Drug: Arvekap 0.1mg (Triptorelin, Ipsen, France)
Drug: Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

Study type

Interventional

Funder types

Other

Identifiers

NCT00417066
poor responders

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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