EndometriosisPhase 4NCT00286351
Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis
A Phase 4 study testing Combined treatment with Arimidex and Zoladex before IVF in people with Endometriosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following IVF outcome Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Combined treatment with Arimidex and Zoladex before IVF
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2005to not given
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Endometrioma(s)with a size of 20-70 mm, persisted for at least 3 cycles
- Couples with indication and wish for IVF/ICSI
- Age of women: 20-40 years
- Regular menstrual cycle within normal range (21-35 days)
- Body Mass Index (BMI): 18-30 kg/m2
Who cannot join
- History with osteoporosis, liver-, kidney- or heart disease or thromboembolic disease
- Treatment of endometriosis with GnRH agonist during the last 3 month
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Copenhagen East, 2100
About this study
Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following IVF outcome
- Conditions
- Endometriosis
- Being tested
- Combined treatment with Arimidex and Zoladex before IVF
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined treatment with Arimidex and Zoladex before IVFDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
size of endometriomas after 2½ month of combined downregulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Kristine Lossl, medical doctor, Principal investigator, The Fertility Clinic, Copenhagen University Hospital Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286351
- Sponsor's protocol ID
- endo 220604
- Status last verified
- Apr 2007
- First submitted
- 1 Feb 2006
- Last updated
- 23 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis
- ClinicalTrials.gov ID
- NCT00286351
- Acronym / sponsor ID
- endo 220604
- Conditions
- Endometriosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2005
- First posted
- 3 Feb 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.
Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following IVF outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Endometrioma(s)with a size of 20-70 mm, persisted for at least 3 cycles
- Couples with indication and wish for IVF/ICSI
- Age of women: 20-40 years
- Regular menstrual cycle within normal range (21-35 days)
- Body Mass Index (BMI): 18-30 kg/m2
Key exclusion criteria (2 listed)
- History with osteoporosis, liver-, kidney- or heart disease or thromboembolic disease
- Treatment of endometriosis with GnRH agonist during the last 3 month
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 |
|---|---|---|
| Combined treatment with Arimidex and Zoladex before IVF | Drug | – |
Primary outcome
size of endometriomas after 2½ month of combined downregulation
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 23 Apr 2007.
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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.
Kristine Lossl, medical doctor principal investigator
The Fertility Clinic, Copenhagen University Hospital Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combined treatment with Arimidex and Zoladex before IVF in people with Endometriosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 5 inclusion and 2 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 23 Apr 2007. 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 Denmark. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
size of endometriomas after 2½ month of combined downregulation. 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 23 Apr 2007.