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IRCT20230514058176N1 IRCT 2023-06-19 Shahid Beheshti University of Medical Sciences Comparison of Hormone replacement therapy with ovarian stimulation as endometrial preparation protocols for frozen thawed embryo transfer Comparison of Hormone replacement therapy with ovarian stimulation as endometrial preparation protocols for frozen thawed embryo transfer 2023-06-21 anticipated 184 Complete https://irct.ir/trial/70107 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will be done in a randomized block fashion. Individual randomization unit is considered. RAS statistical software will be used for block randomization and also for determining the sequence of blocks. All patient information will be recorded in spss26 software. N/A The method of endometrial preparation in the frozen embryo transfer cycle. Intervention 1: Intervention group: Infertile women referred to the infertility treatment center of Mahdieh Hospital, who are in the cycle of frozen embryo transfer, and in order to prepare the endometrium on the third day of menstruation, letrozole tablets (Latrax 2.5 mg, Aburihan Pharmaceuticals) were taken once a day at night for 5 days. Human menopausal gonadotropin (HMG 75 IU) ampoule will be injected intramuscularly once a day for three days. Then a control ultrasound is performed and if the follicle is 17 to 22 mm and the thickness of the endometrium is 6 to 7 mm, the human chorionic gonadotropin ampoule will be administered. (HCG 5000 IU) is injected intramuscularly. 36 hours later, 50 mg progesterone ampoule (Abourihan Company) will be injected intramuscularly for 3 days in the case of three-day-old embryos and 5 days in the case of 5-day-old embryos, and then embryo transfer is performed and two weeks after the transfer, a pregnancy test will be performed. Intervention 2: Control group: Infertile women referred to the infertility treatment center of Mahdieh Hospital, who are in the cycle of frozen embryo transfer, who receive 2 mg estradiol pills (Aburihan Company) three times a day (every 8 hours) to prepare the endometrium on the third day of menstruation. one number) then a control ultrasound is performed and if the follicle reaches 17 to 22 mm and the endometrium thickness reaches 6 to 7 mm, 100 mg progesterone ampoule (Aburihan company) for 3 days in the case of 3-day and 5-day embryos In the case of 5-day-old embryos, the day is injected, and then embryo transfer is performed, and two weeks later, a pregnancy test is performed. 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 There is no more information
public Samira Azimi
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 drazimi48@gmail.com Shahid Beheshti University of Medical Sciences scientific Samia Azimi
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 drazimi48@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Women referring to Mahdiyeh infertility treatment center aged between 18 and 42 years who have frozen embryos Have a normal uterine structure Have a healthy endometrium without endometrial polyps or submucosal myoma 18 years 42 years Female anatomical malformation of uterus ; unicorn. bicorn underlying disease like diabet. thyroid . cardiovascular. immun disease N97.4 Female infertility associated with male factor Treatment - Drugs Treatment - Drugs Intervention group: Infertile women referred to the infertility treatment center of Mahdieh Hospital, who are in the cycle of frozen embryo transfer, and in order to prepare the endometrium on the third day of menstruation, letrozole tablets (Latrax 2.5 mg, Aburihan Pharmaceuticals) were taken once a day at night for 5 days. Human menopausal gonadotropin (HMG 75 IU) ampoule will be injected intramuscularly once a day for three days. Then a control ultrasound is performed and if the follicle is 17 to 22 mm and the thickness of the endometrium is 6 to 7 mm, the human chorionic gonadotropin ampoule will be administered. (HCG 5000 IU) is injected intramuscularly. 36 hours later, 50 mg progesterone ampoule (Abourihan Company) will be injected intramuscularly for 3 days in the case of three-day-old embryos and 5 days in the case of 5-day-old embryos, and then embryo transfer is performed and two weeks after the transfer, a pregnancy test will be performed. Control group: Infertile women referred to the infertility treatment center of Mahdieh Hospital, who are in the cycle of frozen embryo transfer, who receive 2 mg estradiol pills (Aburihan Company) three times a day (every 8 hours) to prepare the endometrium on the third day of menstruation. one number) then a control ultrasound is performed and if the follicle reaches 17 to 22 mm and the endometrium thickness reaches 6 to 7 mm, 100 mg progesterone ampoule (Aburihan company) for 3 days in the case of 3-day and 5-day embryos In the case of 5-day-old embryos, the day is injected, and then embryo transfer is performed, and two weeks later, a pregnancy test is performed. Endometrial thickness: The appropriate thickness of the endometrial layer of the uterus for embryo transfer, which is better to be above 6 to 7 mm to prepare for embryo transfer. Timepoint: The thickness of the endometrium is measured before the start of the treatment and 7-14 days after the intervention. Method of measurement: Endometrial thickness is measured by transvaginal ultrasound. Shahid Beheshti University of Medical Sciences Approved 2023-04-30 Ethic committee of Shahid Beheshti University of Medical Science Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)