Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

NCT ID: NCT01530490

Last Updated: 2012-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Women undergoing IVF cycles with GnRH agonist protocols, at risk of OHSS (more than 20 follicles observed larger than 12 mm in diameter and/or estradiol levels of 3000-5000 pg/mL).

Slow infusion of 500 ml of 6% HES during follicular aspiration alone or combined with 0.5 mg cabergoline administration for 8 days, starting on the day of hCG administration.

Conditions

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Complications Associated With Artificial Fertilization Disorder of Endocrine Ovary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hemoes

Group Type NO_INTERVENTION

No interventions assigned to this group

Cabergoline

cabergoline

Group Type EXPERIMENTAL

Cabergoline and Hydroxyethyl Starch

Intervention Type DRUG

0.5mg

Hydroxyethyl Starch

Intervention Type DRUG

0.5 mg cabergoline administration 8 days

Interventions

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Cabergoline and Hydroxyethyl Starch

0.5mg

Intervention Type DRUG

Hydroxyethyl Starch

0.5 mg cabergoline administration 8 days

Intervention Type DRUG

Other Intervention Names

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Dostinex Hemoes

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age \> 40 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Cruces

OTHER

Sponsor Role lead

Responsible Party

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Roberto Matorras

Head of reproduction Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roberto Matorras, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Cruces

References

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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.

Reference Type DERIVED
PMID: 23932181 (View on PubMed)

Other Identifiers

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CEIC0754

Identifier Type: -

Identifier Source: org_study_id

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