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

Phase 3

Completed

• Conditions: Infertility; Polycystic Ovary Syndrome
• Interventions: Drug: GnRH antagonist (Cetrorelix); Drug: Conventional GnRH agonist (Triptorelin)

• Registration Number: NCT01402336
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-04
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-07
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH antagonist, SD #6 starting group	GnRH antagonist (Cetrorelix)	Start GnRH antagonist from stimulation day 6 during ovulation induction cycles
Conventional GnRH agonist long group	Conventional GnRH agonist (Triptorelin)	Conventional GnRH agonist long protocol
GnRH antagonist, SD #1 starting group	GnRH antagonist (Cetrorelix)	Start GnRH antagonist from stimulation day 1 during ovulation induction cycles

Primary Outcome Measures

Name	Time	Method
number of oocyte retrieved	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

Name	Time	Method
pregnancy rate	after confirming fetal heart beat via transvaginal ultrasound. Usually 2~4 weeks after ovum pick-up day.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of