Polycystic Ovarian SyndromeNCT01569256
Ovarian Hyperstimulation Syndrome and Cabergoline
A study testing Cabergoline in people with Polycystic Ovarian Syndrome and Ovarian Hyperstimulation Syndrome, run by Etlik Zubeyde Hanim Womens' Health and Teaching Hospital.
Trial summary
Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS… Read more about this study
- Who is it for?
- Ages 23 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome, Ovarian Hyperstimulation Syndrome
- What is being tested?
- Cabergoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Mar 2009
- Phase
- Interventional
- 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 23 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Development of more than 14 leading follicles larger than 10 mm and serum estradiol more than 3000 pg/ml at the end of ovulation induction with long luteal ovulation induction protocol.
- Having the criteria of PCOS
Who cannot join
- Not having the inclusion criteria.
About this study
Official title: The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss
Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome (OHSS).
Read the detailed description
Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high risk of OHSS, however the possible mechanism of action has not been clearly known. In experimental studies, inhibition of vascular endothelial growth factor based pathway was proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian hormone (AMH) on cabergoline action in OHSS prevention has not been known.
- Being tested
- Cabergoline
- Medical subject headings
- Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
Also called Dostinex
Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days
| Study group | Role | What they receive |
|---|---|---|
| Cabergoline administered group | Active comparator | The patients in this group will have cabergoline (Dostinex tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days) for prevention of OHSS.
All patients were administered long luteal protocol for ovulation induction. Receives: Drug: Cabergoline |
| Control arm | No intervention | The patients in the control group had no manipulation for prevention of OHSS and age-, BMI-matched with the active comparator group. All patients were administered long luteal protocol for ovulation induction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of follicular fluid AMH
Measured: 1 year
Secondary outcomes (2)
Concentrations of follicular fluid inhibin B
Measured: 1 year
Concentrations of follicular fluid HGF
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
- Responsible party
- Principal investigator, Assoc. Prof. Emine Seda Guvendag Guven, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
- Investigators
- Emine Seda Guvendag Guven, MD, Study chair, Rize University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569256
- Sponsor's protocol ID
- ESG1
- Status last verified
- Apr 2012
- First submitted
- 26 Mar 2012
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss
- ClinicalTrials.gov ID
- NCT01569256
- Acronym / sponsor ID
- ESG1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 3 Apr 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.
Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome (OHSS).
Detailed description
Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high risk of OHSS, however the possible mechanism of action has not been clearly known. In experimental studies, inhibition of vascular endothelial growth factor based pathway was proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian hormone (AMH) on cabergoline action in OHSS prevention has not been known.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cabergoline administered group | Active comparator | Drug: CabergolineThe patients in this group will have cabergoline (Dostinex tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days) for prevention of OHSS. All patients were administered long luteal protocol for ovulation induction. |
| Control arm | No intervention | –The patients in the control group had no manipulation for prevention of OHSS and age-, BMI-matched with the active comparator group. All patients were administered long luteal protocol for ovulation induction. |
Who may qualify
- Ages
- 23 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Development of more than 14 leading follicles larger than 10 mm and serum estradiol more than 3000 pg/ml at the end of ovulation induction with long luteal ovulation induction protocol.
- Having the criteria of PCOS
Key exclusion criteria (1 listed)
- Not having the inclusion criteria.
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 |
|---|---|---|
| CabergolineAlso: DostinexCabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days | Drug | Cabergoline administered group |
Primary outcome
Concentrations of follicular fluid AMH
Time frame: 1 year
2 secondary outcomes
Concentrations of follicular fluid inhibin B
Time frame: 1 year
Concentrations of follicular fluid HGF
Time frame: 1 year
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 4 Apr 2012.
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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.
Emine Seda Guvendag Guven, MD study chair
Rize University, Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Cabergoline in people with Polycystic Ovarian Syndrome and Ovarian Hyperstimulation Syndrome, run by Etlik Zubeyde Hanim Womens' Health and Teaching Hospital.
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 2 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 4 Apr 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.
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?
Concentrations of follicular fluid AMH (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2012.