Ovarian Hyperstimulation SyndromePhase 1/2NCT01009567
Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program
A Phase 1/2 study testing Cabergoline in people with Ovarian Hyperstimulation Syndrome, run by Royan Institute at 1 site in Iran.
Trial summary
The purpose of this study is to investigate the efficacy and safety of cabergoline in prevention of ovarian hyperstimulation syndrome versus albumin in ART program. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- Cabergoline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Jun 2009to Jul 2013
- Phase
- Phase 1/2
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients at risk of developing OHSS, defined by the development of 20-30 follicles larger than 12 mm in diameter and retrieval of more than 20 oocytes
- ovarian stimulation with long protocol
Who cannot join
- coasting cases
Trial locations and contacts
1 site in 1 country.
Iran1 site
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR
Tehran, Tehran Province, 14114
About this study
Official title: Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program
The purpose of this study is to investigate the efficacy and safety of cabergoline in prevention of ovarian hyperstimulation syndrome versus albumin in ART program.
Read the detailed description
Ovarian hyperstimulation syndrome (OHSS) is a iatrogenic potentially life threatening complication of assisted reproduction technologies due to gonadotropin and human chorionic gonadotropin administration. Its severe form has been reported in 1-10% of in vitro fertilization cycles.
Different strategies have been proposed for the prevention of OHSS in high-risk patients, but these approaches do not offer complete protection against the development of ovarian hyperstimulation syndrome (OHSS). Among the selected preventive methods, discontinuing (coasting) gonadotropin therapy and i.v. albumin were by far the most popular choices. Several previous studies have shown that cabergoline is a safe drug, both for mother and conceptus, for the treatment of macroadenoma hyperprolactinemia. We think that this kind of therapy may be safe both for mother and conceptus (as previously shown by several studies on dopamine agonists treatment of hyperprolactinemia during pregnancy), easier, cheaper and probably, more effective than previous OHSS treatments (albumin, steroids, dopamine). There is an urgent need to test cabergoline efficacy in OHSS prevention in high risk patients with a large multicenter study.
The proposal of This study approved by our institutional review boards and institution's ethical committee, and all Participants will sign a written consent before enter to study. Patients entering the intracytoplasmic sperm injection (ICSI) / IVF program in Royan institute and infertility research center in Valieasr hospital in Iran. We use a downregulation protocol with a GnRH agonist (buserelin acetate) as a long protocol for ICSI/ IVF-ET. We evaluate patients for high risk factors of severe OHSS. The inclusion criterion was the collection of >20 oocytes during oocyte retrieval. They allocate by a series of computer-generated random into two groups after the oocytes retrieval. 30 minutes after oocytes retrieval patients in A Group , receive human albumin 20% infusion and in B group receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval then women in all groups will informed about the signs and symptoms of OHSS and counsel to contact with our institute if OHSS develops. Patients will monitor routinely 6days after ET by ultrasonographic examination for ovarian size and for detection of ascites. Moderate to severe OHSS patients hospitalize and evaluate routinely by haematological and biochemical tests. OHSS patients diagnose and classify according to Golan et al 1989.we compare incidence of OHSS and severity of OHSS patients in two groups. Pregnant patients follow until the 12th gestational week.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- Cabergoline, Control
- Keywords
- OHSS
- 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.
CabergolineDrug
Also called B
Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
ControlDrug
Also called A
Receive human albumin 20% infusion
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Receive human albumin 20% infusion Receives: Drug: Control |
| Cabergoline | Experimental | Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval Receives: Drug: Cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage and severity of OHSS in two groups
Measured: 6 days after embryos transfer (ET)
Secondary outcomes (1)
Efficacy and safety of cabergoline and albumin
Measured: 6 days after embryos transfer (ET)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2013
- Study completionJul 2013
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 Ovarian Hyperstimulation 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eniseh Tehraninejad, MD, Study director, Royan InstituteAshraf Moini, MD, Study director, Board scientificMarzieh Shiva, MD, Principal investigator, scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009567
- Sponsor's protocol ID
- Royan-Emb-004
- Status last verified
- Nov 2009
- First submitted
- 5 Nov 2009
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tehraninejad ES, Hafezi M, Arabipoor A, Aziminekoo E, Chehrazi M, Bahmanabadi A. Comparison of cabergoline and intravenous albumin in the prevention of ovarian hyperstimulation syndrome: a randomized clinical trial. J Assist Reprod Genet. 2012 Mar;29(3):259-64. doi: 10.1007/s10815-011-9708-4. Epub 2012 Jan 10.
PubMed 22231013
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program
- ClinicalTrials.gov ID
- NCT01009567
- Acronym / sponsor ID
- Royan-Emb-004
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- OHSS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Nov 2009 (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 investigate the efficacy and safety of cabergoline in prevention of ovarian hyperstimulation syndrome versus albumin in ART program.
Detailed description
Ovarian hyperstimulation syndrome (OHSS) is a iatrogenic potentially life threatening complication of assisted reproduction technologies due to gonadotropin and human chorionic gonadotropin administration. Its severe form has been reported in 1-10% of in vitro fertilization cycles.
Different strategies have been proposed for the prevention of OHSS in high-risk patients, but these approaches do not offer complete protection against the development of ovarian hyperstimulation syndrome (OHSS). Among the selected preventive methods, discontinuing (coasting) gonadotropin therapy and i.v. albumin were by far the most popular choices. Several previous studies have shown that cabergoline is a safe drug, both for mother and conceptus, for the treatment of macroadenoma hyperprolactinemia. We think that this kind of therapy may be safe both for mother and conceptus (as previously shown by several studies on dopamine agonists treatment of hyperprolactinemia during pregnancy), easier, cheaper and probably, more effective than previous OHSS treatments (albumin, steroids, dopamine). There is an urgent need to test cabergoline efficacy in OHSS prevention in high risk patients with a large multicenter study.
The proposal of This study approved by our institutional review boards and institution's ethical committee, and all Participants will sign a written consent before enter to study. Patients entering the intracytoplasmic sperm injection (ICSI) / IVF program in Royan institute and infertility research center in Valieasr hospital in Iran. We use a downregulation protocol with a GnRH agonist (buserelin acetate) as a long protocol for ICSI/ IVF-ET. We evaluate patients for high risk factors of severe OHSS. The inclusion criterion was the collection of >20 oocytes during oocyte retrieval. They allocate by a series of computer-generated random into two groups after the oocytes retrieval. 30 minutes after oocytes retrieval patients in A Group , receive human albumin 20% infusion and in B group receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval then women in all groups will informed about the signs and symptoms of OHSS and counsel to contact with our institute if OHSS develops. Patients will monitor routinely 6days after ET by ultrasonographic examination for ovarian size and for detection of ascites. Moderate to severe OHSS patients hospitalize and evaluate routinely by haematological and biochemical tests. OHSS patients diagnose and classify according to Golan et al 1989.we compare incidence of OHSS and severity of OHSS patients in two groups. Pregnant patients follow until the 12th gestational week.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Drug: ControlReceive human albumin 20% infusion |
| Cabergoline | Experimental | Drug: CabergolineReceive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients at risk of developing OHSS, defined by the development of 20-30 follicles larger than 12 mm in diameter and retrieval of more than 20 oocytes
- ovarian stimulation with long protocol
Key exclusion criteria (1 listed)
- coasting cases
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: BReceive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval | Drug | Cabergoline |
| ControlAlso: AReceive human albumin 20% infusion | Drug | Control |
Primary outcome
Percentage and severity of OHSS in two groups
Time frame: 6 days after embryos transfer (ET)
1 secondary outcome
Efficacy and safety of cabergoline and albumin
Time frame: 6 days after embryos transfer (ET)
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 6 May 2015.
- Derived from this study: PubMed 22231013Tehraninejad ES, Hafezi M, Arabipoor A, Aziminekoo E, Chehrazi M, Bahmanabadi A. Comparison of cabergoline and intravenous albumin in the prevention of ovarian hyperstimulation syndrome: a randomized clinical trial. J Assist Reprod Genet. 2012 Mar;29(3):259-64. doi: 10.1007/s10815-011-9708-4. Epub 2012 Jan 10.
- Related InfoLink provided by the sponsor.
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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.
Eniseh Tehraninejad, MD study director
Royan Institute
Ashraf Moini, MD study director
Board scientific
Marzieh Shiva, MD principal investigator
scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cabergoline in people with Ovarian Hyperstimulation Syndrome, run by Royan Institute at 1 site in Iran.
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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage and severity of OHSS in two groups (time frame: 6 days after embryos transfer (ET)). 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 NCT01009567, 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 6 May 2015.