Title : effect of high power laser on increasing the success rate of IVF in infertility patients with a history of at least one IVF failure: a pilot nonblinded study
Determining the effect of adding high-power laser to routine drug treatment on increasing IVF success rate in infertility patients with a history of at least two IVF failures
Design
clinical trial with a control group, factorial groups. , randomized, pilot study on 100 patients. randomization block randomization
Settings and conduct
patients refer to the infertility clinic of Isfahan University of Medical Sciences after history and examinations .
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1- Infertile women with a history of IVF failure at least twice, who are candidates for repeated IVF according to the diagnosis of a gynecologist.
2- Age 20 to 40 years
Exit criteria:
1- Systemic causes of infertility such as rheumatological diseases
3- Wounds and skin lesions at the place of laser treatment
4- Contraindications to hormone therapy (history of breast or uterine cancer, history of thrombosis, etc.)
5- The patient's lack of consent to continue the study
6- Stop ovulation stimulation for any reason
Intervention groups
the intervention group is treated with laser, on the first to third day of menstruation. estradiol is started with a dose of 6 mg along with aspirin and folic acid. High power laser for 6 session. then 9 to 10 days after the start of estradiol, IVF cycle continues with the progesterone.
The protocol for laser: patients are lying on their backs and the laser device used is a high-power laser from the K LASER brand, made in Italy, and the settings : FH of 20,000, a power of 2 watts, and a wavelength of 880 nm. 2000 joules with a density of 10 j/cm in an area of 20 cm۲ during 15 minutes by a pen probe and placing the probe on the of the abdomen between the navel and the top of the pubic symphysis.
The control group also received the treatment protocol
Main outcome variables
IVF success, endometrial thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231203060255N2
Registration date:2024-06-30, 1403/04/10
Registration timing:registered_while_recruiting
Last update:2024-06-30, 1403/04/10
Update count:0
Registration date
2024-06-30, 1403/04/10
Registrant information
Name
Fateme Hoseinzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3233 0973
Email address
fatemehoseinzade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-02, 1403/01/14
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title : effect of high power laser on increasing the success rate of IVF in infertility patients with a history of at least one IVF failure: a pilot nonblinded study
Public title
Title : effect of high power laser on increasing the success rate of IVF in infertility patients with a history of at least one IVF failure: a pilot nonblinded study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women with history of infertility and at least two time failure of ivf
Exclusion criteria:
systemic or organic etiology for infertility
scar or any skin lesion in site of laser therapy
contraindication of hormone therapy
cancelation of the ovulation
Patient dissatisfaction
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
randomization The study will be done by random block method (randomized block of 4 blocks) in such a way that 100 patients will be randomized under the study of blocks of 4 and 25 blocks, in each block of 4 2 people will be in the hormone therapy group and 2 people will be in the hormone therapy group + Laser
The selection order of the blocks in the 25 selected blocks will be random according to the table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Research Ethics Committee of the "Alzahra Research Centers"
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Approval date
2023-09-27, 1402/07/05
Ethics committee reference number
IR.ARI.MUI.REC.1402.162
Health conditions studied
1
Description of health condition studied
INFERTILITY
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
IVF success
Timepoint
BHCG test measurement two weeks after transfer to confirm pregnancy or non-pregnancy
Method of measurement
BHCG serum level test
Secondary outcomes
1
Description
uterine blood supply
Timepoint
before treatment , The tenth day of the cycle
Method of measurement
sonography
2
Description
Increased thickness of the endometrium
Timepoint
before treatment , The tenth day of the cycle
Method of measurement
sonography
Intervention groups
1
Description
Intervention group: Intervention group: Patients in the intervention group, in addition to the medical treatment of the frozen embryo transfer cycle, are treated with laser in such a way that on the first to third day of menstruation, the patients are subjected to ultrasound by a fixed person who is an expert, and the thickness of the endometrium and the blood supply of the uterus by Ultrasound is checked and then estradiol medicine is started for the patient with a dose of 6 mg per day along with aspirin and folic acid and the patient's laser is also started in the luteal phase (2 days before the start of estradiol) with 6 sessions of high power laser at an interval of 1 It is done every other day (three times a week).Then 9 to 10 days after the start of estradiol, the patient is evaluated again with ultrasound to improve the blood supply of the uterus, and they are also checked for the thickness of the endometrium, and if the thickness of the endometrium is suitable (8-12 mm), the patient's IVF cycle continues with the administration of progesterone. The patient laser protocol is also such that the patients lie supine and the patient laser sessions are conducted by a stationary person and the laser device used is a high-power laser from the K LASER brand, made in Italy, and the fixed settings used for all patients include a frequency of 20 thousand power 2 watts, wavelength 880 nm energy consumption 2000 joules with a density of 10 joules/cm2 in an area of 20 cm2 during fifteen minutes by means of a pen probe and the location of the probe on the surface of the abdomen between the navel and the top of the symphysis pubis
Category
Treatment - Other
2
Description
Control group: In the control group, the treatment protocol of the IVF cycle is started according to the described protocol of estradiol drug at a dose of 6 mg per day along with aspirin and folic acid, and then 9 to 10 days after the start of estradiol, the patient is re-evaluated with ultrasound to improve blood supply to the uterus. They are also checked for the thickness of the endometrium, and if the thickness of the endometrium is suitable (8-12 mm), the patient's IVF cycle continues with the administration of progesterone.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility clinic affiliated to Isfahan University of Medical Science
Full name of responsible person
Hatav Ghasemi Tehran
Street address
Motahari street metal bridge
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
hatav.tehrani2014@gmail.com
Web page address
https://beheshti.mui.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Building No. 4,Hazar Jarib Street,Isfahan University of Medical Sciences
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hatav Ghasemi Tehrani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Hatav.tehrani2014@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Hoseinzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hazar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Fatemehoseinzade98@gamil.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fateme Hoseinzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hazar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
91746734461
Phone
+98 31 3668 0048
Email
Fatemehoseinzade98@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available