Back to resultsCabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention
Primary Purpose
Complications Associated With Artificial Fertilization, Disorder of Endocrine Ovary
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Cabergoline and Hydroxyethyl Starch
Hydroxyethyl Starch
Sponsored by
About this trial
This is an interventional prevention trial for Complications Associated With Artificial Fertilization focused on measuring IVF, ovarian hyperstimulation syndrome, cabergoline, hydroxyethyl starch, prevention
Eligibility Criteria
Inclusion Criteria:
- to be at risk of OHSS were invited to participate in the study
Exclusion Criteria:
- age > 40 years
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Hemoes
Cabergoline
Arm Description
cabergoline
Outcomes
Primary Outcome Measures
risk of ovarian hyperstimulation syndrome
Secondary Outcome Measures
pregnancy rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01530490
Brief Title
Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention
Official Title
Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Cruces
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications Associated With Artificial Fertilization, Disorder of Endocrine Ovary
Keywords
IVF, ovarian hyperstimulation syndrome, cabergoline, hydroxyethyl starch, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemoes
Arm Type
No Intervention
Arm Title
Cabergoline
Arm Type
Experimental
Arm Description
cabergoline
Intervention Type
Drug
Intervention Name(s)
Cabergoline and Hydroxyethyl Starch
Other Intervention Name(s)
Dostinex
Intervention Description
0.5mg
Intervention Type
Drug
Intervention Name(s)
Hydroxyethyl Starch
Other Intervention Name(s)
Hemoes
Intervention Description
0.5 mg cabergoline administration 8 days
Primary Outcome Measure Information:
Title
risk of ovarian hyperstimulation syndrome
Time Frame
12 days
Secondary Outcome Measure Information:
Title
pregnancy rate
Time Frame
15 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
to be at risk of OHSS were invited to participate in the study
Exclusion Criteria:
age > 40 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Matorras, MD, PhD
Organizational Affiliation
Hospital Cruces
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23932181
Citation
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.
Results Reference
derived
Learn more about this trial
Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention
We'll reach out to this number within 24 hrs