InfertilityNCT02594852
Laser - a New Possibility in Fertility Treatment - a Pilot Study
A study testing + laser in people with Infertility and Exposure Laser, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
Trial summary
In this study the investigators want to investigate if the pregnancy rate in conjunction with fertility treatment increases with concomitant use of laser therapy. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Exposure Laser
- What is being tested?
- + laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Apr 2017
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI : 18-32
- long agonist/short antagonist IVF/intracytoplasmatic sperm injection (ICSI)treatment
- 1-2 IVF/ICSI treatments without obtaining pregnancy.
- signed consent
Who cannot join
- uterine malformations
- Uterine fibroids/polyps
- need of an interpreter.
- D.M, epilepsy, liver-kidney-heart disease
- endometrial biopsy
- cancer former cancer disease
Show all 9Show fewer
- acupuncture
- metal in the body
- suspicious naevi and tatoo´s
Trial locations and contacts
1 site in 1 country.
Denmark1 site
the Fertility clinic, Regional Hospital Skive
Skive, Central Jutland, 7800
About this study
In this study the investigators want to investigate if the pregnancy rate in conjunction with fertility treatment increases with concomitant use of laser therapy.
Read the detailed description
Furthermore the investigators want to examine the participants general mental and physical wellbeing during the experimental period using a VAS-scale.
- Conditions
- Infertility, Exposure Laser
- Being tested
- + laser
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
+ laserDevice
Use of laser in the treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention (+ laser) | Experimental | + laser therapy Receives: Device: + laser |
| Non-intervention (- laser) | Placebo comparator | - laser Receives: Device: + laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: up to24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: Too few patients enrolling + laser no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Viborg, Skive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helle Olesen Elbaek, Regionshospitalet Viborg, Skive
- Investigators
- Helle Elbaek, M.D, Study director, The Fertility clinic Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594852
- Sponsor's protocol ID
- 1-10-72-288-14
- Status last verified
- Oct 2017
- First submitted
- 28 May 2015
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser - a New Possibility in Fertility Treatment - a Pilot Study
- ClinicalTrials.gov ID
- NCT02594852
- Acronym / sponsor ID
- 1-10-72-288-14
- Conditions
- Infertility, Exposure Laser
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too few patients enrolling + laser no longer available
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Regionshospitalet Viborg, SkiveUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Nov 2015 (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.
In this study the investigators want to investigate if the pregnancy rate in conjunction with fertility treatment increases with concomitant use of laser therapy.
Detailed description
Furthermore the investigators want to examine the participants general mental and physical wellbeing during the experimental period using a VAS-scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (+ laser) | Experimental | Device: + laser+ laser therapy |
| Non-intervention (- laser) | Placebo comparator | Device: + laser- laser |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI : 18-32
- long agonist/short antagonist IVF/intracytoplasmatic sperm injection (ICSI)treatment
- 1-2 IVF/ICSI treatments without obtaining pregnancy.
- signed consent
Key exclusion criteria (9 listed)
- uterine malformations
- Uterine fibroids/polyps
- need of an interpreter.
- D.M, epilepsy, liver-kidney-heart disease
- endometrial biopsy
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 |
|---|---|---|
| + laserUse of laser in the treatment | Device | Intervention (+ laser), Non-intervention (- laser) |
Primary outcome
Clinical pregnancy rate
Time frame: up to24 months
Results and safety
The study was stopped early (reason given: Too few patients enrolling + laser no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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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.
Helle Elbaek, M.D study director
The Fertility clinic Skive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing + laser in people with Infertility and Exposure Laser, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 3 Oct 2017. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Too few patients enrolling + laser no longer available). Results are not available in the source record.
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?
Clinical pregnancy rate (time frame: up to24 months). 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 3 Oct 2017.