NCT01065376

Brief Summary

The dopamine agonist cabergoline inhibits phosphorylation of the vascular endothelial growth factor receptor-2(VEGFR-2), which prevent vascular endothelial growth factor (VEGF) overexpression and reduce the severity of Ovarian hyperstimulation syndrome. However, VEGF plays an important role in the growth and maintenance of ovarian follicle and developing embryo by mediating angiogenesis.This study was designed to analyze whether the timing cabergoline administration on the day of human chorionic gonadotropin (hCG) injection or after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 21, 2011

Status Verified

April 1, 2011

Enrollment Period

1.4 years

First QC Date

February 8, 2010

Last Update Submit

July 20, 2011

Conditions

In Vitro Fertilization

Keywords

IVFOHSScabergoline

Outcome Measures

Primary Outcomes (1)

  • number of metaphase II oocytes

    one year

Secondary Outcomes (3)

  • embryo quality

    one year

  • pregnancy rate

    one year

  • The incidence of OHSS

    one year

Study Arms (2)

on the day of hCG

EXPERIMENTAL

cabergoline administration for 8 days on the day of hCG.

Procedure: the timing cabergoline administration

on the day after oocyte retrieval

EXPERIMENTAL

cabergoline administration for 8 days on the day after oocyte retrieval

Procedure: the timing cabergoline administration

Interventions

the timing cabergoline administrationPROCEDURE

received 0.5 mg oral cabergoline per day for 8 days on the day of hCG

on the day of hCG

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • the risk of ovarian hyperstimulation syndrome development

You may not qualify if:

  • allergic to cabergoline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Study Officials

  • Jiann-Loung Hwang, MD

    Shin Kong Wu Ho-Su Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

July 21, 2011

Record last verified: 2011-04

Locations

TW(1)