NCT01530490

Brief Summary

The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF) cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2007

Typical duration for early_phase_1

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

August 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

January 26, 2012

Last Update Submit

February 9, 2012

Conditions

Complications Associated With Artificial FertilizationDisorder of Endocrine Ovary

Keywords

IVFovarian hyperstimulation syndromecabergolinehydroxyethyl starchprevention

Outcome Measures

Primary Outcomes (1)

  • risk of ovarian hyperstimulation syndrome

    12 days

Secondary Outcomes (1)

  • pregnancy rate

    15 days

Study Arms (2)

Hemoes

NO INTERVENTION

Cabergoline

EXPERIMENTAL

cabergoline

Drug: Cabergoline and Hydroxyethyl StarchDrug: Hydroxyethyl Starch

Interventions

Cabergoline and Hydroxyethyl StarchDRUG

0.5mg

Also known as: Dostinex
Cabergoline
Hydroxyethyl StarchDRUG

0.5 mg cabergoline administration 8 days

Also known as: Hemoes
Cabergoline

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to be at risk of OHSS were invited to participate in the study

You may not qualify if:

  • age \> 40 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Matorras R, Andres M, Mendoza R, Prieto B, Pijoan JI, Exposito A. Prevention of ovarian hyperstimulation syndrome in GnRH agonist IVF cycles in moderate risk patients: randomized study comparing hydroxyethyl starch versus cabergoline and hydroxyethyl starch. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):439-43. doi: 10.1016/j.ejogrb.2013.07.010. Epub 2013 Aug 8.

    PMID: 23932181DERIVED

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

CabergolineHydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingStarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Roberto Matorras, MD, PhD

    Hospital Cruces

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of reproduction Unit

Study Record Dates

First Submitted

January 26, 2012

First Posted

February 10, 2012

Study Start

August 1, 2007

Primary Completion

August 1, 2008

Study Completion

September 1, 2010

Last Updated

February 10, 2012

Record last verified: 2012-02