Short-Term Androgen Priming Before COS Using Aromatase Inhibitor and hCG During Early-Follicular-Phase GnRH Antagonist Administration - a Randomized Controlled Trial
Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT00286364
Collaborator
(none)
1
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 39 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00286364
Other Study ID Numbers:
- version 01.2005-05-20
- NCT00150501
First Posted:
Feb 3, 2006
Last Update Posted:
Apr 23, 2007
Last Verified:
Apr 1, 2007