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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402336
First Posted: July 26, 2011
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Young Min Choi, Seoul National University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Young Min Choi, 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. ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: after confirming fetal heart beat via transvaginal ultrasound. Usually 2~4 weeks after ovum pick-up day. ]

Enrollment: 43
Study Start Date: June 2011
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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
  • Korean ethnicity

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402336


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

Responsible Party: Young Min Choi, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01402336     History of Changes
Other Study ID Numbers: PCOS_IVF
First Submitted: July 4, 2011
First Posted: July 26, 2011
Last Update Posted: October 10, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Infertility
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Prolactin Release-Inhibiting Factors
Deslorelin
Triptorelin Pamoate
Cetrorelix
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female