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

NCT ID: NCT02594852

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-04-30

Brief Summary

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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

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

Conditions

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Infertility Exposure Laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention (+ laser)

\+ laser therapy

Group Type EXPERIMENTAL

+ laser

Intervention Type DEVICE

Use of laser in the treatment

Non-intervention (- laser)

\- laser

Group Type PLACEBO_COMPARATOR

+ laser

Intervention Type DEVICE

Use of laser in the treatment

Interventions

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+ laser

Use of laser in the treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Regionshospitalet Viborg, Skive

OTHER

Sponsor Role lead

Responsible Party

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Helle Olesen Elbaek

Clinical Director, M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helle Elbaek, M.D

Role: STUDY_DIRECTOR

The Fertility clinic Skive

Locations

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the Fertility clinic, Regional Hospital Skive

Skive, Central Jutland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-288-14

Identifier Type: -

Identifier Source: org_study_id