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

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ClinicalTrials.gov Identifier: NCT00286351
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : April 23, 2007
Sponsor:
Information provided by:
Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Combined treatment with Arimidex and Zoladex before IVF Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources




Primary Outcome Measures :
  1. size of endometriomas after 2½ month of combined downregulation


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286351


Locations
Denmark
The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Copenhagen East, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Kristine Lossl, medical doctor The Fertility Clinic, Copenhagen University Hospital Rigshospitalet

ClinicalTrials.gov Identifier: NCT00286351     History of Changes
Other Study ID Numbers: endo 220604
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: April 23, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female
Anastrozole
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs