Back to resultsUse of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Combined treatment with Arimidex and Zoladex before IVF
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: History with osteoporosis, liver-, kidney- or heart disease or thromboembolic disease Treatment of endometriosis with GnRH agonist during the last 3 month
Sites / Locations
- The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet
Outcomes
Primary Outcome Measures
size of endometriomas after 2½ month of combined downregulation
Secondary Outcome Measures
Full Information
NCT ID
NCT00286351
First Posted
February 1, 2006
Last Updated
April 20, 2007
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00286351
Brief Title
Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief Summary
Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following IVF outcome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Combined treatment with Arimidex and Zoladex before IVF
Primary Outcome Measure Information:
Title
size of endometriomas after 2½ month of combined downregulation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
History with osteoporosis, liver-, kidney- or heart disease or thromboembolic disease
Treatment of endometriosis with GnRH agonist during the last 3 month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Lossl, medical doctor
Organizational Affiliation
The Fertility Clinic, Copenhagen University Hospital Rigshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
State/Province
Copenhagen East
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis
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