Complications Associated With Artificial FertilizationEarly Phase 1NCT01530490
Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention
A Early Phase 1 study testing Cabergoline and Hydroxyethyl Starch and Hydroxyethyl Starch in people with Complications Associated With Artificial Fertilization and Disorder of Endocrine Ovary, run by Hospital de Cruces.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications Associated With Artificial Fertilization, Disorder of Endocrine Ovary
- What is being tested?
- Cabergoline and Hydroxyethyl Starch and Hydroxyethyl Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Sep 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- to be at risk of OHSS were invited to participate in the study
Who cannot join
- age > 40 years
About this study
Official title: Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch
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.
Read the 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.
- Being tested
- Cabergoline and Hydroxyethyl Starch, Hydroxyethyl Starch
- Keywords
- IVF, ovarian hyperstimulation syndrome, cabergoline, hydroxyethyl starch, prevention
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabergoline and Hydroxyethyl StarchDrug
Also called Dostinex
0.5mg
Hydroxyethyl StarchDrug
Also called Hemoes
0.5 mg cabergoline administration 8 days
| Study group | Role | What they receive |
|---|---|---|
| Hemoes | No intervention | Not described |
| Cabergoline | Experimental | cabergoline Receives: Drug: Cabergoline and Hydroxyethyl Starch; Drug: Hydroxyethyl Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of ovarian hyperstimulation syndrome
Measured: 12 days
Secondary outcomes (1)
pregnancy rate
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications Associated With Artificial FertilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Cruces
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Matorras, Hospital de Cruces
- Investigators
- Roberto Matorras, MD, PhD, Principal investigator, Hospital Cruces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530490
- Sponsor's protocol ID
- CEIC0754
- Status last verified
- Feb 2012
- First submitted
- 26 Jan 2012
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23932181
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch
- ClinicalTrials.gov ID
- NCT01530490
- Acronym / sponsor ID
- CEIC0754
- Keywords
- IVF, ovarian hyperstimulation syndrome, cabergoline, hydroxyethyl starch, prevention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital de CrucesUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemoes | No intervention | – |
| Cabergoline | Experimental | Drug: Cabergoline and Hydroxyethyl Starch, Drug: Hydroxyethyl Starchcabergoline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- to be at risk of OHSS were invited to participate in the study
Key exclusion criteria (1 listed)
- age > 40 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabergoline and Hydroxyethyl StarchAlso: Dostinex0.5mg | Drug | Cabergoline |
| Hydroxyethyl StarchAlso: Hemoes0.5 mg cabergoline administration 8 days | Drug | Cabergoline |
Primary outcome
risk of ovarian hyperstimulation syndrome
Time frame: 12 days
1 secondary outcome
pregnancy rate
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
- Derived from this study: PubMed 23932181Matorras 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.
Related trials for Complications Associated With Artificial Fertilization
Not yet recruitingObservational study
Hippo-Related Competing Endogenous RNA (ceRNA) Network Dysregulation and In Vitro Fertilization (IVF) Outcomes in Women With Diminished Ovarian Reserve
Diminished Ovarian Reserve, Female Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Matorras, MD, PhD principal investigator
Hospital Cruces
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cabergoline and Hydroxyethyl Starch and Hydroxyethyl Starch in people with Complications Associated With Artificial Fertilization and Disorder of Endocrine Ovary, run by Hospital de Cruces.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of ovarian hyperstimulation syndrome (time frame: 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01530490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2012.