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

October 2, 2017 updated by: Helle Olesen Elbaek, Regionshospitalet Viborg, Skive
In this study the investigators want to investigate if the pregnancy rate in conjunction with fertility treatment increases with concomitant use of laser therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Furthermore the investigators want to examine the participants general mental and physical wellbeing during the experimental period using a VAS-scale.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Central Jutland
      • Skive, Central Jutland, Denmark, 7800
        • the Fertility clinic, Regional Hospital Skive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. BMI : 18-32
  2. long agonist/short antagonist IVF/intracytoplasmatic sperm injection (ICSI)treatment
  3. 1-2 IVF/ICSI treatments without obtaining pregnancy.
  4. signed consent

Exclusion Criteria:

  1. uterine malformations
  2. Uterine fibroids/polyps
  3. need of an interpreter.
  4. D.M, epilepsy, liver-kidney-heart disease
  5. endometrial biopsy
  6. cancer former cancer disease
  7. acupuncture
  8. metal in the body
  9. suspicious naevi and tatoo´s

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention (+ laser)
+ laser therapy
Device: + laser
Use of laser in the treatment
Placebo Comparator: Non-intervention (- laser)
- laser
Device: + laser
Use of laser in the treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: up to24 months
up to24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regionshospitalet Viborg, Skive

Investigators

  • Study Director: Helle Elbaek, M.D, The Fertility Clinic Skive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-288-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on + laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe