Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis

Endometriosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286351
• Other study ID #: endo 220604
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2006
• Last updated: April 20, 2007
• Start date: January 2005

Study information

• Verified date: April 2007
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following IVF outcome

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Combined treatment with Arimidex and Zoladex before IVF

Locations

Country	Name	City	State
Denmark	The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet	Copenhagen	Copenhagen East

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	size of endometriomas after 2½ month of combined downregulation