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Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients


Phase 4
18 Years
50 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome

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Trial Information

Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients


Women with polycystic ovarian syndrome (PCOS) represent a group of patients at high risk of
developing ovarian hyperstimulation syndrome (OHSS), an iatrogenic complication of ovarian
stimulation during IVF treatment. In contrast to mild OHSS, severe OHSS is a
life-threatening complication, characterized by massive ovarian enlargement, ascites,
pleural effusion, oliguria, haemoconcentration and thromboembolic phenomena. Currently, no
curative therapy for OHSS is available and thus prevention is considered the most effective
“treatment”. Several measures have been adopted to reduce the occurrence of the syndrome,
the most effective being cycle cancellation and withholding of human chorionic gonadotropin
(hCG), which seems to be the most critical factor for the development of OHSS.

COMPARISON: This study aims to compare the development and severity of OHSS, as well as
ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist (Ganirelix)
protocol vs a long GnRH agonist (Arvekap) protocol of ovarian stimulation.


Inclusion Criteria:



- Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic
ovaries)

Exclusion Criteria:

- Normal responders

- Poor responders

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Development of OHSS

Principal Investigator

Tryfon Lainas, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eugonia

Authority:

Greece: National Organization of Medicines

Study ID:

ag vs antag PCOS

NCT ID:

NCT00417144

Start Date:

November 2003

Completion Date:

May 2007

Related Keywords:

  • Polycystic Ovary Syndrome
  • Ovarian Hyperstimulation Syndrome
  • OHSS
  • PCOS
  • GnRH antagonist
  • GnRH agonist
  • Polycystic Ovary Syndrome
  • Ovarian Hyperstimulation Syndrome

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