Laser - a New Possibility in Fertility Treatment - a Pilo... | NCT02594852

Studies
Laser - a New Possibility in Fertility Treatment - a Pilot Study

NCT02594852

Sponsor

Regionshospitalet Viborg, Skive

Status

Terminated

Last Update Posted

Oct 3, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Infertility
Exposure Laser

Interventions

+ laser

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Too few patients enrolling + laser no longer available

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

May 28, 2015

First Submission Date that Met QC Criteria

Nov 2, 2015

First Posted Date

Nov 3, 2015Estimated

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

Oct 2, 2017

Last Update Posted Date

Oct 3, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Helle Olesen Elbaek, Clinical Director, M.D, Regionshospitalet Viborg, SkivePrincipal Investigator

Lead Sponsor

Regionshospitalet Viborg, SkiveOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention (+ laser)	Experimental	+ laser therapy	Device: + laser
Non-intervention (- laser)	Placebo Comparator	- laser	Device: + laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
+ laser	Device	Use of laser in the treatment	Intervention (+ laser) Non-intervention (- laser)

Measure	Description	Time Frame
Clinical pregnancy rate		up to24 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

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
Helle Elbaek, M.D	The Fertility clinic Skive	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the Fertility clinic, Regional Hospital Skive		Skive	Central Jutland	7800	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007834	Lasers

Ancestor Terms

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided