The effect of Low Level Laser Therapy on the rates of implantation and pregnancy in assisted reproduction cycles in patients with repeated implantation failure
Determining the rate of biochemical and clinical pregnancy after treatment of patients with repeated implantation failure with low level laser
Design
Two arm parallel group randomised trial with blinded outcome assessment
Settings and conduct
Women referred to the infertility and IVF clinic of Imam Khomeini Hospital of Tehran University of Medical Sciences who have had at least 3 high-quality embryo transfers and have repeatedly failed implantation and are candidates for frozen embryo transfer (FET) are included in the study.
Participants/Inclusion and exclusion criteria
Women who have had at least 3 high-quality embryo transfers and repeatedly failed implantation and are candidates for frozen embryo transfer (FET) are included .Diagnostic hysteroscopy, is performed in all patients before the start of the embryo transfer cycle. Investigating thrombophilias, hormonal disorders, hematological and immunological disorders, and the karyotype of the couple are done in all cases to investigate the possible causes of RIF.
Exclusion criteria: age over 40 years, BMI more than 30 kg/m2, hematological, immunological, hormonal, chromosomal disorders, hereditary or acquired uterine anomalies, hydrosalpinx, male factor disorders, adenomyosis and pelvic tuberculosis and endometriosis.
Intervention groups
Low-level laser treatment is performed by referring patients to the physiotherapy clinic of Imam Khomeini Hospital with the Diodes ir AIGaAs laser from New Age Company with the following specifications and without charge and after obtaining informed consent from the patient:
Power: 230 v
Frequency: 50/60 Hz
Wavelength: 850 nm
The treatment consist of six 16 minutes sessions, performed during the first 2 weeks of the menstrual cycle, every other day and in the next cycle the embryo transfer cycle begins.
Main outcome variables
biochemical and clinical pregnanacy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100518003950N7
Registration date:2023-04-30, 1402/02/10
Registration timing:prospective
Last update:2023-04-30, 1402/02/10
Update count:1
Registration date
2023-04-30, 1402/02/10
Registrant information
Name
Mina Jafarabadei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
jafarabadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Low Level Laser Therapy on the rates of implantation and pregnancy in assisted reproduction cycles in patients with repeated implantation failure
Public title
The effect of Low Level Laser Therapy on the rates of pregnancy in patients with repeated implantation failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women who have at least 3 recurrent IVF failures with good quality embryos
candidates for freeze embryo transfer (FET)
women who have normal uterus cavity with diagnostic hysteroscopy
women who have normal results for inherited thrombophilia , antiphospholipid syndrome, hormonal status (thyroid, prolactine, blood glucose) ,and karyotype of both couples
age above 18 years
Exclusion criteria:
age above 40 years
BMI more than 30 kg/m2
congenital or acquired uterine anomalies
hydrosalpinx diagnosed by ultrasonography
abnormal male factors
uterine adenomyosis
pelvic tuberculosis
pelvic endometriosis
Age
From 18 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Individual
Randomization tool: clinic supervisor
How to make a random sequence: blocks of 2 alleles of size 4 (AABB, ABBA, ABAB, BAAB, ...)
We decided to assign A to the intervention group (laser) and B to the control group. First, the qualified sample is selected based on the entry and exit criteria, and then it is placed in subgroup A or B according to the constructed blocks. This process continues until 15 items are completed in each group.
For randomization, we used the following site to determine the sequences:
https://www.sealdenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor and the data analyst will not know which group belongs to the intervention group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Seeing the gestational sac and live fetus in vaginal ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:low-power laser treatment with Diodes ir AIGaAs laser from New Age Company with the following specifications and without charge and after obtaining informed consent from the patient: Power: 230 V Frequency: 50/60 Hz Wavelength: 850 nm Treatment sessions with Low power laser consists of 6 sessions (16 minutes each session) which is performed during the first 2 weeks of the menstrual cycle and every other day except for holidays, and in the next cycle after the laser treatment, the embryo transfer cycle begins. The laser device is directly contacted with the skin of the suprapubic area in the anatomical location of the uterus (diagnosed by abdominal ultrasound) and after emptying the bladder, and during the treatment of the uterus by placing a sterile dummy manipulator in the posterior fornix of the vagina (similar to the generator and made with vibril and latex coating with a diameter of 3 cm) is directed to the front so that the maximum laser energy reaches the branches of the endometrial vessels.
Category
Treatment - Other
2
Description
Control group: The patient enters the embryo transfer cycle without additional intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mina Naghijafarabadi
Street address
Keshavarz Blvd. , Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
minajaf@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotoohi
Street address
6th floor., Central Organization of TUMS., Qods Ave., Keshavaraz Blvd.
City
Tehran
Province
Tehran
Postal code
1276141690
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mina Naghi Jafarabadi
Position
Associate Profesoor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital Complex., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2049
Email
minajaf@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Jafarabadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Reproductive Health Research center, Emam Khomeini Hospital Complex, Keshavarz Blvd..
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
minajaf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Jafarabadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali-E-Asr Reproductive Health Research Center., Emam Khomeini Hospital Complex., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
minajaf@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Potentially, after de-identifying individuals, only a portion of the data including information related to the primary outcome can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Any statistical analysis will be allowed. Any use of this analysis that leads to the publication of an article or speech must be obtained with our consent.
From where data/document is obtainable
Dr. Mina Jafarabadi.
minajaf@yahoo.com
What processes are involved for a request to access data/document
Submitting an email to the main researcher and waiting two weeks for a reply.