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GnRH Antagonist Versus GnRH Agonist in Polycystic Ovary Syndrome During in Vitro Fertilization - Embryo Transfer

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Young Min Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01402336
First received: July 4, 2011
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

GnRH (Gonadotropin-releasing hormone) antagonists in IVF (in vitro fertilization) has been accomplished by several randomized controlled trials compared with conventional GnRH agonist long protocol in polycystic ovary syndrome (PCOS) patients. Moreover, there are debating issues that refer to the timing of GnRH antagonist initiation. The purpose of this study is to investigate the laboratory and clinical priority during ovarian stimulation for IVF in patients with PCOS treated with three different protocols.


Condition Intervention Phase
Infertility
Polycystic Ovary Syndrome
 Drug: GnRH antagonist (Cetrotide)
Drug: Conventional GnRH agonist
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 'A Multicentre, Prospective Randomized Study to Assess the Effect When GnRH Antagonist is Started Either on Stimulation Day 1 and Day 6 vs. Conventional GnRH Agonist Long Protocol in Patients With Polycystic Ovary Syndrome Undergoing IVF-ET(in Vitro Fertilization - Embryo Transfer)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • number of oocyte retrieved [ Time Frame: ovum pick up day, At the point of ovum pick-up, we can count how many oocyte was retrieved. So, almost just after ovum pick-up, outcome measure will be possible. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: after confirming fetal heart beat via transvaginal ultrasound. Usually 2~4 weeks after ovum pick-up day. ] [ Designated as safety issue: No ]

Estimated Enrollment: 267
Study Start Date: June 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GnRH antagonist, SD(stimulation day) #1 starting group
Start GnRH antagonist from stimulation day 1 during ovulation induction cycles
 Drug: GnRH antagonist (Cetrotide)
In the first arm, cetrotide will be administrated from the first day during stimulation. In the second arm, cetrotide will be administrated from the sixth day during stimulation
Experimental: GnRH antagonist, SD #6 starting group
Start GnRH antagonist from stimulation day 6 during ovulation induction cycles
 Drug: GnRH antagonist (Cetrotide)
In the first arm, cetrotide will be administrated from the first day during stimulation. In the second arm, cetrotide will be administrated from the sixth day during stimulation
Active Comparator: Conventional GnRH agonist long group
Conventional GnRH agonist long protocol
 Drug: Conventional GnRH agonist
Patients in the agonist group were administered GnRH agonist started 5 days before discontinuation of the oral contraceptive.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PCOS patients (diagnosed as 2003 ASRM(The American Society for Reproductive Medicine)/ESHRE(The European Society of Human Reproduction and Embryology) consensus meeting guideline)
  • age 20-40 years
  • patients who have normal uterus

Exclusion Criteria:

  • patients who have abnormal thyroid function
  • patients who have abnormal prolactin test
  • patients who have diabetes, or Cushing's syndrome, or congenital adrenal hyperplasia, or androgen-producing tumor.
  • Patients who reject informed consent
  • patients who have experience of adverse events for GnRH agonist, antagonist, recombinant FSH(follicle-stimulating hormone).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402336

Contacts
Contact: Young Min Choi, M.D., Ph. D +82-2-2072-2385 ymchoi@snu.ac.kr
Contact: Kyung Eui Park, M.D. +82-2-2072-3529 kepark.md@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Young Min Choi, M.D., Ph.D.            
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Young Min Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01402336     History of Changes
Other Study ID Numbers: PCOS_IVF
Study First Received: July 4, 2011
Last Updated: April 11, 2013
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Polycystic ovary syndrome
ovulation induction
In vitro fertilization-embryo transfer

Additional relevant MeSH terms:
Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Cetrorelix
Deslorelin
Triptorelin
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013