'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
Overview
- Phase
- Phase 3
- Intervention
- GnRH antagonist (Cetrorelix)
- Conditions
- Infertility
- Sponsor
- Seoul National University Hospital
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- number of oocyte retrieved
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Young Min Choi
Young Min Choi
Seoul National University Hospital
Eligibility 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).
Arms & Interventions
GnRH antagonist, SD #1 starting group
Start GnRH antagonist from stimulation day 1 during ovulation induction cycles
Intervention: GnRH antagonist (Cetrorelix)
GnRH antagonist, SD #6 starting group
Start GnRH antagonist from stimulation day 6 during ovulation induction cycles
Intervention: GnRH antagonist (Cetrorelix)
Conventional GnRH agonist long group
Conventional GnRH agonist long protocol
Intervention: Conventional GnRH agonist (Triptorelin)
Outcomes
Primary Outcomes
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 Outcomes
- pregnancy rate(after confirming fetal heart beat via transvaginal ultrasound. Usually 2~4 weeks after ovum pick-up day.)