Use of Acetyl Salicylic Acid and Terbutalin in Assisted R... | NCT00518141

Studies
Use of Acetyl Salicylic Acid and Terbutalin in Assisted Reproductive Techniques (ART)

NCT00518141

Sponsor

Sykehuset Telemark

Status

Completed

Last Update Posted

Jul 21, 2011Estimated

Enrollment

300Actual

Phase

Not Applicable

Conditions

Reproductive Techniques, Assisted

Interventions

Acetyl Salicylic Acid and Terbutalin

Countries

Norway

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

Jul 2011

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

Mar 2006

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Aug 17, 2007

First Submission Date that Met QC Criteria

Aug 17, 2007

First Posted Date

Aug 20, 2007Estimated

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

Jul 20, 2011

Last Update Posted Date

Jul 21, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and Terbutalin on ART treatment.

Detailed Description

This study aims to determine the possible effects of ASA and Terbutalin on ART treatment.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	FER	Drug: Acetyl Salicylic Acid and Terbutalin
2	No Intervention	FER
3	Experimental	SET	Drug: Acetyl Salicylic Acid and Terbutalin
4	No Intervention	SET
5	Experimental	DET	Drug: Acetyl Salicylic Acid and Terbutalin
6	No Intervention	DET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acetyl Salicylic Acid and Terbutalin	Drug	ASA 75 mg, Terbutalin 5mg	1 3 5

Measure	Description	Time Frame
Pregnancy		7 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infertile women below 39 years of age

Exclusion Criteria:

Women who may react allergically to the drugs administered
Women with hyperthyroid or IDDM
Women who do not want to participate in the study
Women who are unable to give informed, written consent.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jarl A Kahn, Dr. med	STHF, Kvinneklinikken, Fertilitetsklinikken Sor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
STHF, Kvinneklinikken, Fertilitetsklinikken Sor		Porsgrunn	Telemark	3901	Norway

Condition Browse Module

MeSH Terms

ID	Term
D006379	Helping Behavior

Ancestor Terms

ID	Term
D012919	Social Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013726	Terbutaline

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided