Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients

NCT00417144 | Unknown Phase 4

• 1 other identifier: ag vs antag PCOS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome

Keywords

OHSS; PCOS; GnRH antagonist; GnRH agonist

Outcome Measures

Primary Outcomes (2)

• Development of OHSS

• Ongoing pregnancy rate per embryo transfer

Secondary Outcomes (3)

• Biochemical pregnancy

• Clinical pregnancy

• Embryological data

Interventions

Arvekap 0.1mg (Triptorelin, Ipsen, France) DRUG

Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands) DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Normal responders
• Poor responders

Sponsors & Collaborators

• Eugonia: lead

Study Sites (1)

Eugonia

Athens, 11528, Greece

RECRUITING

Related Publications (2)

• 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.

  PMID: 12859048 BACKGROUND

• 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.

  PMID: 20008886 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome

Interventions

Triptorelin Pamoate; ganirelix

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Tryfon Lainas, PhD

  Eugonia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tryfon Lainas, PhD

CONTACT

00302107236333; ivf@eugonia.com.gr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2006
• First Posted: December 29, 2006
• Study Start: November 1, 2003
• Study Completion: May 1, 2007
• Last Updated: December 29, 2006

Record last verified: 2006-12

Locations

GR (1)