Back to resultsLaser - a New Possibility in Fertility Treatment - a Pilot Study
Primary Purpose
Infertility, Exposure Laser
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
+ laser
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- BMI : 18-32
- long agonist/short antagonist IVF/intracytoplasmatic sperm injection (ICSI)treatment
- 1-2 IVF/ICSI treatments without obtaining pregnancy.
- signed consent
Exclusion Criteria:
- uterine malformations
- Uterine fibroids/polyps
- need of an interpreter.
- D.M, epilepsy, liver-kidney-heart disease
- endometrial biopsy
- cancer former cancer disease
- acupuncture
- metal in the body
- suspicious naevi and tatoo´s
Sites / Locations
- the Fertility clinic, Regional Hospital Skive
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention (+ laser)
Non-intervention (- laser)
Arm Description
+ laser therapy
- laser
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02594852
First Posted
May 28, 2015
Last Updated
October 2, 2017
Sponsor
Regionshospitalet Viborg, Skive
1. Study Identification
Unique Protocol Identification Number
NCT02594852
Brief Title
Laser - a New Possibility in Fertility Treatment - a Pilot Study
Official Title
Laser - a New Possibility in Fertility Treatment - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Too few patients enrolling + laser no longer available
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionshospitalet Viborg, Skive
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Furthermore the investigators want to examine the participants general mental and physical wellbeing during the experimental period using a VAS-scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Exposure Laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (+ laser)
Arm Type
Experimental
Arm Description
+ laser therapy
Arm Title
Non-intervention (- laser)
Arm Type
Placebo Comparator
Arm Description
- laser
Intervention Type
Device
Intervention Name(s)
+ laser
Intervention Description
Use of laser in the treatment
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
up to24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI : 18-32
long agonist/short antagonist IVF/intracytoplasmatic sperm injection (ICSI)treatment
1-2 IVF/ICSI treatments without obtaining pregnancy.
signed consent
Exclusion Criteria:
uterine malformations
Uterine fibroids/polyps
need of an interpreter.
D.M, epilepsy, liver-kidney-heart disease
endometrial biopsy
cancer former cancer disease
acupuncture
metal in the body
suspicious naevi and tatoo´s
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helle Elbaek, M.D
Organizational Affiliation
The Fertility clinic Skive
Official's Role
Study Director
Facility Information:
Facility Name
the Fertility clinic, Regional Hospital Skive
City
Skive
State/Province
Central Jutland
ZIP/Postal Code
7800
Country
Denmark
12. IPD Sharing Statement
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Laser - a New Possibility in Fertility Treatment - a Pilot Study
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