Use of Arimidex and Zoladex as Pretreatment to IVF in Wom... | NCT00286351

Studies
Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis

NCT00286351

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Apr 23, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Endometriosis

Interventions

Combined treatment with Arimidex and Zoladex before IVF

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 1, 2006

First Submission Date that Met QC Criteria

Feb 1, 2006

First Posted Date

Feb 3, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2007

Last Update Posted Date

Apr 23, 2007Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Combined treatment with Arimidex and Zoladex before IVF	Drug

Measure	Description	Time Frame
size of endometriomas after 2½ month of combined downregulation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Endometrioma(s)with a size of 20-70 mm, persisted for at least 3 cycles
Couples with indication and wish for IVF/ICSI
Age of women: 20-40 years
Regular menstrual cycle within normal range (21-35 days)
Body Mass Index (BMI): 18-30 kg/m2

Exclusion Criteria:

History with osteoporosis, liver-, kidney- or heart disease or thromboembolic disease
Treatment of endometriosis with GnRH agonist during the last 3 month

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristine Lossl, medical doctor	The Fertility Clinic, Copenhagen University Hospital Rigshospitalet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet		Copenhagen	Copenhagen East	2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003131	Combined Modality Therapy
D000077384	Anastrozole

Ancestor Terms

ID	Term
D013812	Therapeutics
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles

Browse Leaves

Not provided

Browse Branches

Not provided