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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Infertility; Polycystic Ovary Syndrome

Treatments: Drug: GnRH antagonist (Cetrorelix); Drug: Conventional GnRH agonist (Triptorelin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01402336

PCOS_IVF

Details and patient eligibility

About

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.

Full description

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

Enrollment: 43 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 3 patient groups

GnRH antagonist, SD #1 starting group

Experimental group

Description:

Start GnRH antagonist from stimulation day 1 during ovulation induction cycles

Treatment:

Drug: GnRH antagonist (Cetrorelix)

GnRH antagonist, SD #6 starting group

Experimental group

Description:

Start GnRH antagonist from stimulation day 6 during ovulation induction cycles

Treatment:

Drug: GnRH antagonist (Cetrorelix)

Conventional GnRH agonist long group

Active Comparator group

Description:

Conventional GnRH agonist long protocol

Treatment:

Drug: Conventional GnRH agonist (Triptorelin)