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Short-Term Androgen Priming Before COS Using Aromatase Inhibitor and hCG During Early-Follicular-Phase GnRH Antagonist Administration - a Randomized Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00286364
First Posted: February 3, 2006
Last Update Posted: April 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose
We want to investigate if early follicular phase downregulation and androgen priming, by use of GnRH antagonist, aromatase inhibitor and hCG before COH in a short protocol, shows signs of improvement compared to standard short antagonist protocol

Condition Intervention Phase
Infertility Drug: Downregulation and androgen priming by use of GnRH antagonist, aromatase inhibitor and hCG before COH Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Rigshospitalet, Denmark:

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication and wish for IVF/ICSI treatment
  • Womens age 20-39 years (both inclusive)
  • Regular menstrual cycle within normal range
  • Body Mass Index: 18-30 kg/m2 (both inclusive)
  • Negative pregnancy test before treatment
  • A maximum of 3 earlier IVF/ICSI treatments that did not result in pregnancy

Exclusion Criteria:

  • serious systemic disease
  • Presence of polycystic ovarian syndrome (PCOS)
  • Earlier poor response with less than 4 mature follicles
  • Earlier participation in the investigation
  Contacts and Locations
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): NCT00286364


Locations
Denmark
The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet
Copenhagen, Copenhagen East, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Kristine Lossl, medical doctor The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00286364     History of Changes
Obsolete Identifiers: NCT00150501
Other Study ID Numbers: version 01.2005-05-20
First Submitted: February 1, 2006
First Posted: February 3, 2006
Last Update Posted: April 23, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Androgens
Aromatase Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists