Back to results

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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00286364

First Posted

February 1, 2006

Last Updated

April 20, 2007

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT00286364

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristine Lossl, medical doctor

Organizational Affiliation

The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet

City

Copenhagen

State/Province

Copenhagen East

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

18487212

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs