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NCT Number: NCT00417066

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

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.

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Key information

Conditions

Infertility Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Premature Ovarian Failure Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Eugonia

Athens, 11528, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)

Drug

Arvekap 0.1mg (Triptorelin, Ipsen, France)

Drug

Primary outcomes

  1. Ongoing pregnancy rate per embryo transfer

Secondary outcomes

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

  2. Number of mature oocytes retrieved.

  3. Number of fertilised oocytes.

Sponsors and collaborators

Lead sponsor

Eugonia

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Dec 29, 2006
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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