NCT00440258

Brief Summary

The present study was designed to provide clinical confirmation of Cb2's value as a new approach in the prevention of increased vascular permeability and hemoconcentration, both signs of OHSS in humans, and in order to explore its mechanism of action. To this end, a prospective, randomized, placebo-controlled study was designed in which Cb2 was employed in women at risk of OHSS after gonadotropin administration for ART. Simultaneously, ovarian perfusion was assessed in these patients using MR pharmacokinetic modeling.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
Last Updated

February 27, 2007

Status Verified

February 1, 2007

First QC Date

February 23, 2007

Last Update Submit

February 26, 2007

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

Ovarian hyperstimulation syndrome, dopamine agonists, cabergoline, hemoconcentration, ascites, ovarian perfusion, dopamine receptor 2

Interventions

CabergolineDRUG
MRPROCEDURE
UltrasoundPROCEDURE
Blood AnalysisPROCEDURE

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old healthy women, with risk of developing OHSS.

You may not qualify if:

  • No risk of developing OHSS; \< 20 oocytes retrieved.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Hyperstimulation SyndromeAscites

Interventions

CabergolineHigh-Energy Shock WavesHematologic Tests

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Antonio Pellicer, MD

    IVI VALENCIA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 26, 2007

Study Start

April 1, 2004

Study Completion

July 1, 2006

Last Updated

February 27, 2007

Record last verified: 2007-02