Reproductive Techniques, AssistedNCT00518141
Use of Acetyl Salicylic Acid and Terbutalin in Assisted Reproductive Techniques (ART)
A study testing Acetyl Salicylic Acid and Terbutalin in people with Reproductive Techniques, Assisted, run by Sykehuset Telemark at 1 site in Norway.
Trial summary
This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and Terbutalin on ART treatment. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Reproductive Techniques, Assisted
- What is being tested?
- Acetyl Salicylic Acid and Terbutalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2006to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women below 39 years of age
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
STHF, Kvinneklinikken, Fertilitetsklinikken Sor
Porsgrunn, Telemark, 3901
About this study
Official title: Use of Acetylsalicylic Acid and Terbutalin in ART
This study aims to determine the possible effects of Acetyl Salicylic Acid (ASA) and Terbutalin on ART treatment.
Read the detailed description
This study aims to determine the possible effects of ASA and Terbutalin on ART treatment.
- Conditions
- Reproductive Techniques, Assisted
- Being tested
- Acetyl Salicylic Acid and Terbutalin
- Medical subject headings
- Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetyl Salicylic Acid and TerbutalinDrug
ASA 75 mg, Terbutalin 5mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FER Receives: Drug: Acetyl Salicylic Acid and Terbutalin |
| 2 | No intervention | FER |
| 3 | Experimental | SET Receives: Drug: Acetyl Salicylic Acid and Terbutalin |
| 4 | No intervention | SET |
| 5 | Experimental | DET Receives: Drug: Acetyl Salicylic Acid and Terbutalin |
| 6 | No intervention | DET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startMar 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive Techniques, AssistedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Investigators
- Jarl A Kahn, Dr. med, Principal investigator, STHF, Kvinneklinikken, Fertilitetsklinikken Sor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518141
- Sponsor's protocol ID
- S-06085 (REK)
- Status last verified
- Jul 2011
- First submitted
- 17 Aug 2007
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Acetylsalicylic Acid and Terbutalin in ART
- ClinicalTrials.gov ID
- NCT00518141
- Acronym / sponsor ID
- S-06085 (REK)
- Conditions
- Reproductive Techniques, Assisted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Study start
- Mar 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Acetyl Salicylic Acid and TerbutalinFER |
| 2 | No intervention | –FER |
| 3 | Experimental | Drug: Acetyl Salicylic Acid and TerbutalinSET |
| 4 | No intervention | –SET |
| 5 | Experimental | Drug: Acetyl Salicylic Acid and TerbutalinDET |
| 6 | No intervention | –DET |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertile women below 39 years of age
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetyl Salicylic Acid and TerbutalinASA 75 mg, Terbutalin 5mg | Drug | 1, 3, 5 |
Primary outcome
Pregnancy
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarl A Kahn, Dr. med principal investigator
STHF, Kvinneklinikken, Fertilitetsklinikken Sor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetyl Salicylic Acid and Terbutalin in people with Reproductive Techniques, Assisted, run by Sykehuset Telemark at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.