NCT02594852

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 3, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

May 28, 2015

Last Update Submit

October 2, 2017

Conditions

InfertilityExposure Laser

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    up to24 months

Study Arms (2)

Intervention (+ laser)

EXPERIMENTAL

\+ laser therapy

Device: + laser

Non-intervention (- laser)

PLACEBO COMPARATOR

\- laser

Device: + laser

Interventions

+ laserDEVICE

Use of laser in the treatment

Intervention (+ laser)Non-intervention (- laser)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Fertility clinic, Regional Hospital Skive

Skive, Central Jutland, 7800, Denmark

Location

MeSH Terms

Conditions

Infertility

Interventions

Lasers

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Helle Elbaek, M.D

    The Fertility clinic Skive

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director, M.D

Study Record Dates

First Submitted

May 28, 2015

First Posted

November 3, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 3, 2017

Record last verified: 2017-10

Locations

DK(1)