Clinical trial NCT00417144: Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients
Official title: Randomized Controlled Trial Comparing the Effect of GnRH Agonist and Antagonist Ovarian Stimulation Protocols in PCOS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Ovarian Hyperstimulation Syndrome
Keywords: OHSS
PCOS
GnRH antagonist
GnRH agonist
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2006-12-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Normal responders
* Poor responders

Primary outcomes:
measure: Development of OHSS
measure: Ongoing pregnancy rate per embryo transfer
Secondary outcomes:
measure: Biochemical pregnancy
measure: Clinical pregnancy
measure: Embryological data
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia
Study officials:
affiliation: Eugonia
name: Tryfon Lainas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aboulghar MA, Mansour RT. Ovarian hyperstimulation syndrome: classifications and critical analysis of preventive measures. Hum Reprod Update. 2003 May-Jun;9(3):275-89. doi: 10.1093/humupd/dmg018.
citation: Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Alexopoulou E, Kolibianakis EM. Flexible GnRH antagonist protocol versus GnRH agonist long protocol in patients with polycystic ovary syndrome treated for IVF: a prospective randomised controlled trial (RCT). Hum Reprod. 2010 Mar;25(3):683-9. doi: 10.1093/humrep/dep436. Epub 2009 Dec 15.