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IRCT20130603013566N11 IRCT 2023-03-12 Vice chancellor for Research,Tabriz University Of Medical Sciences Comparison of two methods of estrogen and progesterone hormone administration and endometrial preparation in normal ovarian cycle in endometrial preparation for embryo transfer. Comparison of freeze embryo transfer cycle results in modified natural cycle versus hormone replacement therapy 2023-03-16 anticipated 150 Complete https://irct.ir/trial/68967 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and control groups using block randomization based on generated numbers by Random allocation software. Thus, in this software, first the number of groups and the total number of the sample size will be entered, and then in the block section, the Block randomization method will be implemented. Patients will be allocated to intervention or control groups based on generated numbers. 3 Infertility. Intervention 1: In the patients of the intervention group, where the preparation of the endometrium will be done by the administration of estrogen and progesterone hormones (artificial or HRT), the 2 mg estradiol pill will start from the second day of the menstrual cycle. On the second and third day, one number every 12 hours and then one number every 8 hours.10 to 12 days after taking estradiol, the next visit will be done and the thickness of the endometrium will be measured by transvaginal ultrasound. If the thickness of the endometrium is equal to or higher than 7.5 mm, injectable progesterone with a dose of 50 mg will be started, first one and then two daily.On the fourth day of starting progesterone, the transfer will be done.Luteal phase support will be done with 400 mg rectal progesterone suppositories every 12 hours and 50 mg progesterone ampoules every three days. In the 10th to 12th day visit, if the thickness of the endometrium is less than 7.5 mm, estradiol will be continued with the same dose or, if needed, higher doses, and the patient will be visited 3 to 4 days later and the endometrial examination will be repeated with ultrasound, and this work will be repeated until reaching The endometrium will continue to be 7.5 mm or more thick.If the thickness of the endometrium does not increase after a maximum of 20 days of taking estradiol, the treatment cycle will be stopped and the patient will be excluded from the study. The information related to the interrupted cycles will be mentioned in the results, but it will not be included in the examination of the results of the embryo transfer cycles. Intervention 2: Control group:In the control group, the endometrium preparation method will be modified with a normal menstrual cycle.On the first to third day of the menstrual cycle, the patient will be visited and transvaginal ultrasound will be performed.Patients will be visited again on the 10th to 12th day of the menstrual cycle and the size of the ovarian follicles and the thickness of the endometrium will be evaluated with transvaginal ultrasound.If the follicle is 17 mm or larger, the ampoule and the thickness of the endometrium is higher than 7.5 mm and the serum progesterone is below 1.5 nanograms/ml, the HCG ampoule will be prescribed with a dose of 5000 units.If there is no dominant follicle of 17 mm or larger, re-visit every 1-2 days will continue until the mentioned results are achieved.If the desired results are not achieved, the cycle will be canceled up to 20 days, and if the serum progesterone level is higher than 1.5 ng/ml on the 10-12 day visit, the embryo transfer cycle will be stopped due to the impossibility of detecting the exact time of ovulation. became .The day of HCG injection is considered as day zero. From the second day, 400 mg progesterone suppository or 50 mg progesterone ampoule will be prescribed to the patient once a day. And on the fifth day, 2 grade A embryos will be transferred to the uterus in the cleavage stage. Luteal phase support will continue with one 400 mg rectal suppository. 14 days after the embryo transfer, a pregnancy test will be performed, and if pregnancy is achieved, two weeks later, an ultrasound will be performed to check the pregnancy status. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the completion of the project, the decision will be made.
public Kobra Hamdi
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 35519161 lahroudin@gmail.com Tabriz University of Medical Sciences scientific Kobra Hamdi
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 35519161 lahroudin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 39 years Having regular periods History of one failed transfer 20 years 39 years Female Congenital uterine anomalies Uterine fibroids Severe endometriosis Previous history of failed transfer more than twice Endometrial thickness less than 7.5 mm N97.0 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs In the patients of the intervention group, where the preparation of the endometrium will be done by the administration of estrogen and progesterone hormones (artificial or HRT), the 2 mg estradiol pill will start from the second day of the menstrual cycle. On the second and third day, one number every 12 hours and then one number every 8 hours.10 to 12 days after taking estradiol, the next visit will be done and the thickness of the endometrium will be measured by transvaginal ultrasound. If the thickness of the endometrium is equal to or higher than 7.5 mm, injectable progesterone with a dose of 50 mg will be started, first one and then two daily.On the fourth day of starting progesterone, the transfer will be done.Luteal phase support will be done with 400 mg rectal progesterone suppositories every 12 hours and 50 mg progesterone ampoules every three days. In the 10th to 12th day visit, if the thickness of the endometrium is less than 7.5 mm, estradiol will be continued with the same dose or, if needed, higher doses, and the patient will be visited 3 to 4 days later and the endometrial examination will be repeated with ultrasound, and this work will be repeated until reaching The endometrium will continue to be 7.5 mm or more thick.If the thickness of the endometrium does not increase after a maximum of 20 days of taking estradiol, the treatment cycle will be stopped and the patient will be excluded from the study. The information related to the interrupted cycles will be mentioned in the results, but it will not be included in the examination of the results of the embryo transfer cycles. Control group:In the control group, the endometrium preparation method will be modified with a normal menstrual cycle.On the first to third day of the menstrual cycle, the patient will be visited and transvaginal ultrasound will be performed.Patients will be visited again on the 10th to 12th day of the menstrual cycle and the size of the ovarian follicles and the thickness of the endometrium will be evaluated with transvaginal ultrasound.If the follicle is 17 mm or larger, the ampoule and the thickness of the endometrium is higher than 7.5 mm and the serum progesterone is below 1.5 nanograms/ml, the HCG ampoule will be prescribed with a dose of 5000 units.If there is no dominant follicle of 17 mm or larger, re-visit every 1-2 days will continue until the mentioned results are achieved.If the desired results are not achieved, the cycle will be canceled up to 20 days, and if the serum progesterone level is higher than 1.5 ng/ml on the 10-12 day visit, the embryo transfer cycle will be stopped due to the impossibility of detecting the exact time of ovulation. became .The day of HCG injection is considered as day zero. From the second day, 400 mg progesterone suppository or 50 mg progesterone ampoule will be prescribed to the patient once a day. And on the fifth day, 2 grade A embryos will be transferred to the uterus in the cleavage stage. Luteal phase support will continue with one 400 mg rectal suppository. 14 days after the embryo transfer, a pregnancy test will be performed, and if pregnancy is achieved, two weeks later, an ultrasound will be performed to check the pregnancy status. Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: HCG β blood test. Number of gestational sacs. Timepoint: From week 5 of pregnancy. Method of measurement: Vaginal ultrasound. Fetal growth. Timepoint: From the beginning of the intervention to the end of pregnancy. Method of measurement: Ultrasound. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2023-03-06 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor; Central Building of Number2; Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)