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IRCT20130603013566N14 IRCT 2024-10-14 Vice chancellor for Research, Tabriz University Of Medical Sciences comparison of hormone replacement therapy and mild ovarian stimulation for endometrial preparation in frozen embryo transfer in patients with polycystic ovarian syndrome comparison of hormone replacement therapy and mild ovarian stimulation for endometrial preparation in frozen embryo transfer in patients with polycystic ovarian syndrome 2024-10-22 anticipated 100 Complete https://irct.ir/trial/78341 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: Intervention group A: 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. Intervention 2: Intervention Group B: In the second group, endometrial preparation will be conducted using a mild ovarian stimulation method. Letrozole 5 mg (2 tablets of 2.5 mg) will be prescribed daily from the second or third day of menstruation for a duration of 5 days. Subsequently, FSH will be administered at a dose of 37.5 to a maximum of 150 mg daily or on alternate days (with a minimum of 2 doses and an increase in dosage if necessary). When at least one follicle exceeds 17 mm in size and the thickness of the uterine endometrium is more than 7.5 mm (provided that there are 14 to 16 follicles or fewer), HCG will be injected. One ampule of 5000 units of HCG will be administered. If more than three follicles are enlarged in total, to prevent OHSS, 1-2 cycles will be canceled, and embryo transfer will not be performed. The next day, a 400 mg rectal progesterone suppository will be started with one unit every night, and then 5-6 days after HCG injection, embryo transfer will be conducted at the cleavage stage. The 400 mg rectal progesterone suppository will continue until the pregnancy test is performed and, in the case of pregnancy, will continue until week 12. The number of transferred embryos and their grades will be recorded for each patient. In both groups, only grade 1 and grade 2 embryos will be transferred. Grade one embryos are defined as having blastomeres of equal size without cytoplasmic fragments. Grade two embryos have blastomeres of equal size with minimal cytoplasmic fragments. Grade three embryos have blastomeres that appear to be of the same size with slight cytoplasmic fragments. Grade four embryos have blastomeres of equal or unequal size with a significant number of cytoplasmic fragments. Finally, grade five embryos are characterized by blastomeres of varying sizes and a very high number of cytoplasmic fragments. Fourteen days after embryo transfer, a beta-hCG test will be conducted, and the pregnancy test results (positive or negative) will be recorded and compared in both groups. In patients with a positive pregnancy test, an abdominal ultrasound will be performed two weeks later to visualize the gestational sac, count, and check for fetal heart rate, and results will be compared in the group. Pregnant women will be monitored for fetal growth and the risk of miscarriage until the end of week 12 of pregnancy. 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 study is completed, it will be decided.
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) Infertile women aged between 20 and 40 years Infertility factor of polycystic ovary syndrome 20 years 40 years Female Congenital uterine anomalies Uterine fibroids Severe endometriosis Previous history of failed transfer more than twice N97.0 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs Intervention group A: 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. Intervention Group B: In the second group, endometrial preparation will be conducted using a mild ovarian stimulation method. Letrozole 5 mg (2 tablets of 2.5 mg) will be prescribed daily from the second or third day of menstruation for a duration of 5 days. Subsequently, FSH will be administered at a dose of 37.5 to a maximum of 150 mg daily or on alternate days (with a minimum of 2 doses and an increase in dosage if necessary). When at least one follicle exceeds 17 mm in size and the thickness of the uterine endometrium is more than 7.5 mm (provided that there are 14 to 16 follicles or fewer), HCG will be injected. One ampule of 5000 units of HCG will be administered. If more than three follicles are enlarged in total, to prevent OHSS, 1-2 cycles will be canceled, and embryo transfer will not be performed. The next day, a 400 mg rectal progesterone suppository will be started with one unit every night, and then 5-6 days after HCG injection, embryo transfer will be conducted at the cleavage stage. The 400 mg rectal progesterone suppository will continue until the pregnancy test is performed and, in the case of pregnancy, will continue until week 12. The number of transferred embryos and their grades will be recorded for each patient. In both groups, only grade 1 and grade 2 embryos will be transferred. Grade one embryos are defined as having blastomeres of equal size without cytoplasmic fragments. Grade two embryos have blastomeres of equal size with minimal cytoplasmic fragments. Grade three embryos have blastomeres that appear to be of the same size with slight cytoplasmic fragments. Grade four embryos have blastomeres of equal or unequal size with a significant number of cytoplasmic fragments. Finally, grade five embryos are characterized by blastomeres of varying sizes and a very high number of cytoplasmic fragments. Fourteen days after embryo transfer, a beta-hCG test will be conducted, and the pregnancy test results (positive or negative) will be recorded and compared in both groups. In patients with a positive pregnancy test, an abdominal ultrasound will be performed two weeks later to visualize the gestational sac, count, and check for fetal heart rate, and results will be compared in the group. Pregnant women will be monitored for fetal growth and the risk of miscarriage until the end of week 12 of pregnancy. 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 until the end of the 12th week of pregnancy. Method of measurement: Ultrasound. Vice chancellor for Research, Tabriz University Of Medical Sciences Approved 2024-09-23 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor, Number 2 Central Building, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)