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:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00286364
First received: February 1, 2006
Last updated: April 20, 2007
Last verified: April 2007
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: February 1, 2006
Last Updated: April 20, 2007
Health Authority: Denmark: National Board of Health

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
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014