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

Primary Purpose

Infertility, Polycystic Ovary Syndrome

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GnRH antagonist (Cetrorelix)

Conventional GnRH agonist (Triptorelin)

About this trial

This is an interventional treatment trial for Infertility focused on measuring Polycystic ovary syndrome, ovulation induction, In vitro fertilization-embryo transfer

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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).

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

GnRH antagonist, SD #1 starting group

GnRH antagonist, SD #6 starting group

Conventional GnRH agonist long group

Arm Description

Start GnRH antagonist from stimulation day 1 during ovulation induction cycles

Start GnRH antagonist from stimulation day 6 during ovulation induction cycles

Conventional GnRH agonist long protocol

Outcomes

Primary Outcome Measures

number of oocyte retrieved

Secondary Outcome Measures

pregnancy rate

Full Information

NCT ID

NCT01402336

First Posted

July 4, 2011

Last Updated

October 7, 2017

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01402336

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

December 31, 2016 (Actual)

Study Completion Date

December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndrome, ovulation induction, In vitro fertilization-embryo transfer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GnRH antagonist, SD #1 starting group

Arm Type

Experimental

Arm Description

Start GnRH antagonist from stimulation day 1 during ovulation induction cycles

Arm Title

GnRH antagonist, SD #6 starting group

Arm Type

Experimental

Arm Description

Start GnRH antagonist from stimulation day 6 during ovulation induction cycles

Arm Title

Conventional GnRH agonist long group

Arm Type

Active Comparator

Arm Description

Conventional GnRH agonist long protocol

Intervention Type

Drug

Intervention Name(s)

GnRH antagonist (Cetrorelix)

Other Intervention Name(s)

Cetrotide

Intervention Description

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

Intervention Name(s)

Conventional GnRH agonist (Triptorelin)

Other Intervention Name(s)

Decapeptyl

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

pregnancy rate

Time Frame

after confirming fetal heart beat via transvaginal ultrasound. Usually 2~4 weeks after ovum pick-up day.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

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

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