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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00417144
Other study ID # ag vs antag PCOS
Secondary ID
Status Recruiting
Phase Phase 4
First received December 22, 2006
Last updated December 28, 2006
Start date November 2003
Est. completion date May 2007

Study information

Verified date December 2006
Source Eugonia
Contact Tryfon Lainas, PhD
Phone 00302107236333
Email ivf@eugonia.com.gr
Is FDA regulated No
Health authority Greece: National Organization of Medicines
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Normal responders

- Poor responders

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Arvekap 0.1mg (Triptorelin, Ipsen, France)

Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)


Locations

Country Name City State
Greece Eugonia Athens

Sponsors (1)

Lead Sponsor Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Aboulghar MA, Mansour RT. Ovarian hyperstimulation syndrome: classifications and critical analysis of preventive measures. Hum Reprod Update. 2003 May-Jun;9(3):275-89. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Development of OHSS
Primary Ongoing pregnancy rate per embryo transfer
Secondary Biochemical pregnancy
Secondary Clinical pregnancy
Secondary Embryological data
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