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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 5, 2013
Last verified: December 2013
  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 (Cetrorelix)
Drug: Conventional GnRH agonist (Triptorelin)
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

Resource links provided by NLM:


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 #1 starting group
Start GnRH antagonist from stimulation day 1 during ovulation induction cycles
Drug: GnRH antagonist (Cetrorelix)
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
Other Name: Cetrotide
Experimental: GnRH antagonist, SD #6 starting group
Start GnRH antagonist from stimulation day 6 during ovulation induction cycles
Drug: GnRH antagonist (Cetrorelix)
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
Other Name: Cetrotide
Active Comparator: Conventional GnRH agonist long group
Conventional GnRH agonist long protocol
Drug: Conventional GnRH agonist (Triptorelin)
Patients in the agonist group were administered GnRH agonist started 5 days before discontinuation of the oral contraceptive.
Other Name: Decapeptyl

Detailed Description:

GnRH Antagonist is Started on Stimulation Day 1 GnRH Antagonist is Started on Stimulation Day 6 Conventional GnRH Agonist Long Protocol

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Kyoung Yong Moon, M.D. +82-2-2072-3529 jordan9981@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
Investigators
Principal Investigator: Young Min Choi, M.D., Ph.D. 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: December 5, 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:
Polycystic Ovary Syndrome
Infertility
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Deslorelin
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014