NCT01402336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

5.6 years

First QC Date

July 4, 2011

Last Update Submit

October 7, 2017

Conditions

InfertilityPolycystic Ovary Syndrome

Keywords

Polycystic ovary syndromeovulation inductionIn vitro fertilization-embryo transfer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • pregnancy rate

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

Study Arms (3)

GnRH antagonist, SD #1 starting group

EXPERIMENTAL

Start GnRH antagonist from stimulation day 1 during ovulation induction cycles

Drug: GnRH antagonist (Cetrorelix)

GnRH antagonist, SD #6 starting group

EXPERIMENTAL

Start GnRH antagonist from stimulation day 6 during ovulation induction cycles

Drug: GnRH antagonist (Cetrorelix)

Conventional GnRH agonist long group

ACTIVE COMPARATOR

Conventional GnRH agonist long protocol

Drug: Conventional GnRH agonist (Triptorelin)

Interventions

GnRH antagonist (Cetrorelix)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

Also known as: Cetrotide
GnRH antagonist, SD #1 starting groupGnRH antagonist, SD #6 starting group
Conventional GnRH agonist (Triptorelin)DRUG

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

Also known as: Decapeptyl
Conventional GnRH agonist long group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

InfertilityPolycystic Ovary Syndrome

Interventions

cetrorelixTriptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Young Min Choi, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Young Min Choi

Study Record Dates

First Submitted

July 4, 2011

First Posted

July 26, 2011

Study Start

June 1, 2011

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

October 10, 2017

Record last verified: 2017-10

Locations

KR(1)