Ovarian Hyperstimulation SyndromePhase 2NCT00329693
Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide
A Phase 2 study testing Norprolac in people with Ovarian Hyperstimulation Syndrome, run by Ferring Pharmaceuticals at 7 sites in Spain.
Trial summary
Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS. Read more about this study
- Who is it for?
- Ages 21 to 37 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- Norprolac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 7 sitesSpain
- Study dates
- Jun 2006to May 2008
- Phase
- Phase 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 21 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed Informed Consent Form, prior to screening evaluations
- In good physical and mental health
- Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation
- Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility
Who cannot join
- Any clinically significant systemic disease
- Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
- History of recurrent miscarriage
- Undiagnosed vaginal bleeding
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
IVI Barcelona, Ronda General Mitre, 14
Barcelona, 08017
IVI Bilbao, Paseo Landabarri, 1
Leioa-Bizkaia, 48940
IVI Madrid, Santiago de Compostela, 88
Madrid, 28035
IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota
Murcia, 30007
IVI Sevilla, Avda. República Argentina, 58
Seville, 41011
IVI Valencia, Plaza de la Policía Local, 3
Valencia, 46015
IVI Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)
Vigo (Pontevedra), 36203
About this study
Official title: A Randomised, Double-blind, Parallel Groups, Dose-finding, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of 3-wk Treatment With 1 of 3 Oral Doses of Quinagolide & Placebo in Preventing Ovarian Hyperstimulation Syndrome in Women Undergoing Controlled Ovarian Hyperstimulation.
Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.
Read the detailed description
No data to be entered.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- Norprolac
- 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.
NorprolacDrug
Placebo
NorprolacDrug
Quinagolide
NorprolacDrug
Quinagolide
NorprolacDrug
Quinagolide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Daily Tablets Dosing Receives: Drug: Norprolac |
| 2 | Experimental | Daily Tablets Dose Receives: Drug: Norprolac |
| 3 | Experimental | Daily Tablets Dosing Receives: Drug: Norprolac |
| 4 | Experimental | Daily Tablets Dosing Receives: Drug: Norprolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHSS
Measured: 41 days after hCG injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startJun 2006
- Primary completionAug 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329693
- Sponsor's protocol ID
- FE999051 CS01
- Status last verified
- May 2011
- First submitted
- 23 May 2006
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.
PubMed 33851429Busso C, Fernandez-Sanchez M, Garcia-Velasco JA, Landeras J, Ballesteros A, Munoz E, Gonzalez S, Simon C, Arce JC, Pellicer A. The non-ergot derived dopamine agonist quinagolide in prevention of early ovarian hyperstimulation syndrome in IVF patients: a randomized, double-blind, placebo-controlled trial. Hum Reprod. 2010 Apr;25(4):995-1004. doi: 10.1093/humrep/deq005. Epub 2010 Feb 6.
PubMed 20139430
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Parallel Groups, Dose-finding, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of 3-wk Treatment With 1 of 3 Oral Doses of Quinagolide & Placebo in Preventing Ovarian Hyperstimulation Syndrome in Women Undergoing Controlled Ovarian Hyperstimulation.
- ClinicalTrials.gov ID
- NCT00329693
- Acronym / sponsor ID
- FE999051 CS01
- Conditions
- Ovarian Hyperstimulation Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 May 2006 (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.
Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.
Detailed description
No data to be entered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: NorprolacDaily Tablets Dosing |
| 2 | Experimental | Drug: NorprolacDaily Tablets Dose |
| 3 | Experimental | Drug: NorprolacDaily Tablets Dosing |
| 4 | Experimental | Drug: NorprolacDaily Tablets Dosing |
Who may qualify
- Ages
- 21 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed Informed Consent Form, prior to screening evaluations
- In good physical and mental health
- Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation
- Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility
Key exclusion criteria (4 listed)
- Any clinically significant systemic disease
- Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
- History of recurrent miscarriage
- Undiagnosed vaginal bleeding
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 |
|---|---|---|
| NorprolacPlacebo | Drug | 1 |
| NorprolacQuinagolide | Drug | 2 |
| NorprolacQuinagolide | Drug | 3 |
| NorprolacQuinagolide | Drug | 4 |
Primary outcome
OHSS
Time frame: 41 days after hCG injection
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 19 May 2011.
- Derived from this study: PubMed 33851429Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.
- Derived from this study: PubMed 20139430Busso C, Fernandez-Sanchez M, Garcia-Velasco JA, Landeras J, Ballesteros A, Munoz E, Gonzalez S, Simon C, Arce JC, Pellicer A. The non-ergot derived dopamine agonist quinagolide in prevention of early ovarian hyperstimulation syndrome in IVF patients: a randomized, double-blind, placebo-controlled trial. Hum Reprod. 2010 Apr;25(4):995-1004. doi: 10.1093/humrep/deq005. Epub 2010 Feb 6.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Norprolac in people with Ovarian Hyperstimulation Syndrome, run by Ferring Pharmaceuticals at 7 sites in Spain.
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 4 inclusion and 4 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. 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 phase mean?
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?
OHSS (time frame: 41 days after hCG injection). 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 NCT00329693, which also lists 2 linked publications.
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 19 May 2011.