NCT00286364

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
Last Updated

April 23, 2007

Status Verified

April 1, 2007

First QC Date

February 1, 2006

Last Update Submit

April 20, 2007

Conditions

Infertility

Interventions

Downregulation and androgen priming by use of GnRH antagonist, aromatase inhibitor and hCG before COHDRUG

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet

Copenhagen, Copenhagen East, 2100, Denmark

Location

Related Publications (1)

  • Lossl K, Andersen CY, Loft A, Freiesleben NL, Bangsboll S, Andersen AN. Short-term androgen priming by use of aromatase inhibitor and hCG before controlled ovarian stimulation for IVF. A randomized controlled trial. Hum Reprod. 2008 Aug;23(8):1820-9. doi: 10.1093/humrep/den131. Epub 2008 May 15.

    PMID: 18487212DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Down-RegulationAromatase Inhibitors

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Biochemical PhenomenaChemical PhenomenaGene Expression RegulationGenetic PhenomenaPharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological PhenomenaSteroid Synthesis InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEstrogen AntagonistsHormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of Drugs

Study Officials

  • Kristine Lossl, medical doctor

    The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Last Updated

April 23, 2007

Record last verified: 2007-04

Locations

DK(1)