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IRCT20230206057338N1 IRCT 2023-12-07 Tabriz University of Medical Sciences Investigating the effect of electrotherapy in improving uterine blood supply in women with a history of repeated IVF implantation failure Investigating the effect of electrotherapy in improving uterine blood supply in women with a history of repeated IVF implantation failure 2023-11-26 anticipated 22 Complete https://irct.ir/trial/73926 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method will be used for randomization. Central randomization will be performed on the web using a random faith system with a 1:1 feature ratio. The allocation sequence is created by the person who is not participating in the study process and using random numbers generated by The selection of blocks will continue until the division of 22 patients into two groups (electrotherapy intervention group (PT) and conventional drug treatment control group (C)).The selected blocks will be recorded as a consecutive sequence and a number from 1 to 22 will be assigned to each of the PT and C letters in the created sequence. According to this sequence, the people included in the study will be assigned to one of the two groups of electrotherapy (PT) or conventional drug treatment (C). Due to the unpredictability of the sequence created by the block randomization method, all researchers except the allocator will be unaware of the size and order of the blocks, Blinding description: Due to the nature of the study, it is impossible to blind the participants, the gynecologist and the therapist who applies the electrotherapy treatment. However, the laboratory technician and sonographer will be blinded to the intervention group allocation. N/A Infertility related to women with a history of at least two implantation failures (RIF).. Intervention 1: Intervention group: Pelvic electrotherapy. They receive the usual medical treatment. From the 6th to the 12th day of the cycle, oral amlodipine is prescribed once a day at a dose of 5 mg. Intervention group: pelvic electrotherapy. For electrotherapy, electric current with internal frequency of 150 Hz, closed frequency of 2 Hz, pulse duration of 250 milliseconds and variable amplitude between 0 and 90 will be used for 30 minutes. Electrical stimulation will be done using a vaginal electrode. The patient is placed in a supine position with bent knees. The pelvic floor physiotherapist pours the required amount of lubricating gel on the vaginal electrode and inserts the electrode into the vagina. Then the device is turned on with the mentioned settings and the intensity of the current is increased to the tolerance threshold of the patient. For tecartherapy, heat is provided using capacitive electrodes with a frequency of 300 kHz for 20 minutes. For this, we first cover the abdomen and sacrum using a layer of special cream for the device. Then, a passive metal electrode is placed in the sacrum area and the single pole active electrode with a diameter of 0.5 cm is moved around the uterus and ovaries by the pelvic floor physiotherapist. Pelvic floor exercises are divided into four phases. The proprioceptive phase in the first week includes proprioceptive exercises to adequately understand the exercises and perform fast and slow contractions. The simple phase in the second week aims to improve the control of fast and slow contractions during simple performance activities. The advanced phase in the third week, in which functional exercises with a greater range are performed. The strength phase is done in the last week to increase the strength of the contraction. In all sessions, contractions will be performed for slow and fast fibers. Intervention 2: Control group: Conventional drug therapy. They receive only the usual medical treatment. From the 6th to the 12th day of the cycle, once a day amlodipine is administered orally at a dose of 5 mg. Yes - There is a plan to make this available What will be shared: The information related to the main and secondary outcome, the method of electrotherapy after deidentifying people, informed consent form and completed questionnaires, statistical analysis and spss file, study protocol, codes used in the analysis, data dictionary can be subscribed. When: The access period starts 6 months after the publication of the relevant articles To whom: Permission to receive data or other study documents will be granted only to researchers working in academic and scientific institutions Conditions: If you request more information to refer to the article or use it for further research in the field of electrotherapy and infertility Where to obtain: By sending a message to the e-mail address of Zahra Chakeri at the following address: z.chakeri@gmail.com How to obtain: Sending a message by the requester, checking the message, correspondence to find out the original request, finding the requested items and sending to the requester. The process takes a maximum of one month Comments:
public Zahra Chakeri
Department of Physiotherapy .,Faculty of Rehabilitation .,Tabriz University of Medical Sciences.,29 Bahman Boulevard .,Tabriz .,East Azerbaijan
Tabriz Iran (Islamic Republic of) 5156937895 098 45 3252 1719 Z.chakeri@gmail.com Tabriz University of Medical Sciences scientific Fariba Ghaderi
Department of Physiotherapy .,Faculty of Rehabilitation .,Tabriz University of Medical Sciences.,29 Bahman Boulevard .,Tabriz .,East Azerbaijan
Tabriz Iran (Islamic Republic of) 5156937895 +98 41 3337 2072 Ghaderimailbox@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Female Age between 20 and 40 years History of at least two failed transfers Embryo grade A or B 20 years 40 days Female Having any of the cases of congenital anomaly of the uterus, fibroids or any intrauterine lesions, severe endometriosis, uterine myomas, uterine adenomyosis, ovarian cysts and antral follicles with sizes larger than 12 mm, severe ovulation disorder including prolonged oligoamenorrhea, premature ovarian failure and hypothalamic amenorrhea, suffering from any internal disease associated with blood flow disorders such as diabetes and dyslipidemia, smoking and alcohol consumption, special diets such as vegetarianism, autoimmune diseases, hypertension and coagulation disorders, intrauterine adhesions ( Asherman syndrome)and other organic injuries, uterine dysplasia, mental illnesses, mental disorders, contraindications for estrogen therapy, anemia, hyperthyroidism, heart disease, liver disease, kidney disease, and other diseases that lead to a decrease in menstruation People whose embryos are not grade A or B after resuscitation or the thickness of the endometrium is less than 6 mm on the day of endometrial conversion, N97 Female infertility Rehabilitation Treatment - Drugs Intervention group: Pelvic electrotherapy. They receive the usual medical treatment. From the 6th to the 12th day of the cycle, oral amlodipine is prescribed once a day at a dose of 5 mg. Intervention group: pelvic electrotherapy. For electrotherapy, electric current with internal frequency of 150 Hz, closed frequency of 2 Hz, pulse duration of 250 milliseconds and variable amplitude between 0 and 90 will be used for 30 minutes. Electrical stimulation will be done using a vaginal electrode. The patient is placed in a supine position with bent knees. The pelvic floor physiotherapist pours the required amount of lubricating gel on the vaginal electrode and inserts the electrode into the vagina. Then the device is turned on with the mentioned settings and the intensity of the current is increased to the tolerance threshold of the patient. For tecartherapy, heat is provided using capacitive electrodes with a frequency of 300 kHz for 20 minutes. For this, we first cover the abdomen and sacrum using a layer of special cream for the device. Then, a passive metal electrode is placed in the sacrum area and the single pole active electrode with a diameter of 0.5 cm is moved around the uterus and ovaries by the pelvic floor physiotherapist. Pelvic floor exercises are divided into four phases. The proprioceptive phase in the first week includes proprioceptive exercises to adequately understand the exercises and perform fast and slow contractions. The simple phase in the second week aims to improve the control of fast and slow contractions during simple performance activities. The advanced phase in the third week, in which functional exercises with a greater range are performed. The strength phase is done in the last week to increase the strength of the contraction. In all sessions, contractions will be performed for slow and fast fibers. Control group: Conventional drug therapy. They receive only the usual medical treatment. From the 6th to the 12th day of the cycle, once a day amlodipine is administered orally at a dose of 5 mg. Primary outcome: successful pregnancyoutcomes of the research. Timepoint: Before entering the study,12 weeks after implantation. Method of measurement: To check a successful pregnancy, the implantation rate, the number of gestational sacs and the growth of the fetus until the 12th week of pregnancy will be recorded and analyzed and compared. Arterial resistance index. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: Examination of arterial resistance index is done using transvaginal ultrasound. To identify the state of uterine blood supply, the blood flow changes of the uterine arteries, arcuate artery and subendometrial vessels will be investigated in the follicular stage. Measurements will be reported independently for the right and left uterine arteries. Arterial pulsatility index. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: Examination of arterial pulsatility index is done using transvaginal ultrasound. To identify the state of uterine blood supply, the blood flow changes of the uterine arteries, arcuate artery and subendometrial vessels will be investigated in the follicular stage. Measurements will be reported independently for the right and left uterine arteries. Peak systolic velocity. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: Examination of peak systolic velocity is done using transvaginal ultrasound. To identify the state of uterine blood supply, the blood flow changes of the uterine arteries, arcuate artery and subendometrial vessels will be investigated in the follicular stage. Measurements will be reported independently for the right and left uterine arteries. End diastolic velocity. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: Examination of end diastolic velocity is done using transvaginal ultrasound. To identify the state of uterine blood supply, the blood flow changes of the uterine arteries, arcuate artery and subendometrial vessels will be investigated in the follicular stage. Measurements will be reported independently for the right and left uterine arteries. Endometrial pattern. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: Evaluation of the endometrial pattern is done using transvaginal ultrasound. Endometrial thickness. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: Evaluation of endometrial thickness is done using transvaginal ultrasound. FSH hormone level. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: The level of FSH hormones is obtained by performing a blood test. Sexual performance index. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: The FSFI index is used to measure women's sexual performance in six different areas of sexual desire, arousal, fluidity, orgasm, satisfaction and pain. The level of depression. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: The BDI questionnaire is used to check the level of depression. Quality of Life. Timepoint: Before entering the study, after drug and electrotherapy intervention (after 1 Month). Method of measurement: the SQOL-F questionnaire will be used to check the quality of sexual life in women. Tabriz University of Medical Sciences Student Research Committee grant project Approved 2023-10-02 Ethics committee of Tabriz University of Medical Sciences No. 23, Nasr Ave., Golkar Blvd., Tabriz City Tabriz East Azarbaijan Iran (Islamic Republic of)