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

NCT ID: NCT01402336

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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

Conditions

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Infertility Polycystic Ovary Syndrome

Keywords

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Polycystic ovary syndrome ovulation induction In vitro fertilization-embryo transfer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GnRH antagonist, SD #1 starting group

Start GnRH antagonist from stimulation day 1 during ovulation induction cycles

Group Type EXPERIMENTAL

GnRH antagonist (Cetrorelix)

Intervention Type DRUG

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

GnRH antagonist, SD #6 starting group

Start GnRH antagonist from stimulation day 6 during ovulation induction cycles

Group Type EXPERIMENTAL

GnRH antagonist (Cetrorelix)

Intervention Type DRUG

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

Conventional GnRH agonist long group

Conventional GnRH agonist long protocol

Group Type ACTIVE_COMPARATOR

Conventional GnRH agonist (Triptorelin)

Intervention Type DRUG

Patients in the agonist group were administered GnRH agonist started 5 days before discontinuation of the oral contraceptive.

Interventions

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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

Intervention Type DRUG

Conventional GnRH agonist (Triptorelin)

Patients in the agonist group were administered GnRH agonist started 5 days before discontinuation of the oral contraceptive.

Intervention Type DRUG

Other Intervention Names

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Cetrotide Decapeptyl

Eligibility Criteria

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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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Min Choi

Young Min Choi

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Min Choi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PCOS_IVF

Identifier Type: -

Identifier Source: org_study_id