Protocol summary
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Study aim
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Determining the rate of biochemical and clinical pregnancy after treatment of patients with repeated implantation failure with low level laser
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Design
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Two arm parallel group randomised trial with blinded outcome assessment
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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 24.9 kg/m2, hematological, immunological, hormonal, chromosomal disorders, hereditary or acquired uterine anomalies, hydrosalpinx, male factor disorders, adenomyosis and pelvic tuberculosis and endometriosis.
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Intervention groups
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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: 900 milliwatts
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.
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Main outcome variables
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Biochemical and clinical pregnancy rate
General information
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Reason for update
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To increase the feasibility of the study and the effectiveness of laser therapy on target organ
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100518003950N7
Registration date:
2023-04-30, 1402/02/10
Registration timing:
prospective
Last update:
2024-04-15, 1403/01/27
Update count:
1
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Registration date
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2023-04-30, 1402/02/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-05-10, 1402/02/20
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Expected recruitment end date
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2023-09-11, 1402/06/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect of Low-Level Laser Therapy on Implantation and Pregnancy Rates in Asisted Reproductive Techniques in Patients with Recurrent Implantation Failure
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Public title
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The Effect of Low-Level Laser Therapy on Implantation and Pregnancy Rates in Asisted Reproductive Techniques in Patients with Recurrent Implantation Failure
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 24.9 kg/m2
Congenital or acquired uterine anomalies
Hydrosalpinx diagnosed by ultrasonography
Abnormal male factors
Uterine adenomyosis
Pelvic tuberculosis
Pelvic endometriosis
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Age
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From 18 years old to 39 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The outcome assessor and the data analyst will not know which group belongs to the intervention group
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-07-19, 1401/04/28
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Ethics committee reference number
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IR.TUMS.IKHC.REC.1401.096
Health conditions studied
1
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Description of health condition studied
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Recurrent Implantation Failure (RIF)
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ICD-10 code
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N97
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ICD-10 code description
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Female infertility
2
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Description of health condition studied
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Infertility
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Biochemical pregnancy rate
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Timepoint
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Two weeks after embryo transfer
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Method of measurement
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Blood sample Beta-Human Chorionic Gonadotropin (BHCG) measurement
2
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Description
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Clinical pregnancy rate
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Timepoint
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Five weeks after embryo transfer
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Method of measurement
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Seeing the gestational sac and live fetus in vaginal ultrasound
Intervention groups
1
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Description
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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: 900 milliwats 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.
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Category
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Treatment - Other
2
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Description
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Control group: The patient enters the embryo transfer cycle without additional intervention.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Potentially, after de-identifying individuals, only a portion of the data including information related to the primary outcome can be shared.
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When the data will become available and for how long
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The access period starts 6 months after the results are published.
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To whom data/document is available
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The data will be available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Dr. Mina Jafarabadi.
minajaf@yahoo.com
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What processes are involved for a request to access data/document
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Submitting an email to the main researcher and waiting two weeks for a reply.
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Comments
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