Goserelin and Anastrozole and Combined treatment with Arimidex and Zoladex before IVF in Endometriosis - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Endometriosis

Intervention / Treatment

Drug: Combined treatment with Arimidex and Zoladex before IVF

Study Type

Interventional

Enrollment

20

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- Copenhagen East
  - Copenhagen, Copenhagen East, Denmark, 2100
    - The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
size of endometriomas after 2½ month of combined downregulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

Principal Investigator: Kristine Lossl, medical doctor, The Fertility Clinic, Copenhagen University Hospital Rigshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Registration Dates

First Submitted

February 1, 2006

First Submitted That Met QC Criteria