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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

NCT ID: NCT00286364

Last Updated: 2007-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Kristine Lossl, medical doctor

Role: PRINCIPAL_INVESTIGATOR

The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet

Locations

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The Fertility Clinic 4071, Copenhagen University Hospital Rigshospitalet

Copenhagen, Copenhagen East, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 18487212 (View on PubMed)

Other Identifiers

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version 01.2005-05-20

Identifier Type: -

Identifier Source: org_study_id

NCT00150501

Identifier Type: -

Identifier Source: nct_alias