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

Study 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

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

Conditions
-----------------
Infertility, Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: GnRH antagonist (Cetrorelix)
* Drug: Conventional GnRH agonist (Triptorelin)


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH antagonist, SD #1 starting group<br>Start GnRH antagonist from stimulation day 1 during ovulation induction cycles | Drug: GnRH antagonist (Cetrorelix)<br>* 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<br>* Other names: Cetrotide;|
| Experimental: GnRH antagonist, SD #6 starting group<br>Start GnRH antagonist from stimulation day 6 during ovulation induction cycles | Drug: GnRH antagonist (Cetrorelix)<br>* 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<br>* Other names: Cetrotide;|
| Active Comparator: Conventional GnRH agonist long group<br>Conventional GnRH agonist long protocol | Drug: Conventional GnRH agonist (Triptorelin)<br>* Patients in the agonist group were administered GnRH agonist started 5 days before discontinuation of the oral contraceptive.<br>* Other names: Decapeptyl;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | after confirming fetal heart beat via transvaginal ultrasound. Usually 2 4 weeks after ovum pick-up day. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic ovary syndrome, ovulation induction, In vitro fertilization-embryo transfer