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IRCT20110602006689N4 IRCT 2021-09-08 Tehran University of Medical Sciences The effect of intrauterine hCG injection before embryo transfer on pregnancy rate in frozen embryo transfer cycles The effect of intrauterine hCG injection before embryo transfer on pregnancy rate in frozen embryo transfer cycles 2021-09-22 anticipated 300 Complete https://irct.ir/trial/55758 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: We use the block randomization method to randomize subjects into groups that result in equal sample sizes. We use the block size 4. From the following blocks, first select 1 by accident and divide the samples into two groups according to the order and fill the blocks A for intervention and B for placebo B A B A 2) B B A A 1) B A A B 4) A B B A 3) A A B B 6) A B A B 5), Blinding description: This study is single-blind and the participants would not know about the type of treatment. 3 Infertility. Intervention 1: Intervention group: in 2-3rd day of mensuration period, after baseline ultrasound, ensuring uterine and ovarian suppression and ovarian pathologies role out, 2 mg estradiol will be started every 12 hours and will be adjusted based on endometrial response. After preparing the endometrium, the thickness of the endometrium reaches the appropriate level by performing serial ultrasound, the participants receives progesterone suppositories for 4 days and 4 minutes before embryo transfer, 500 units of hCG (volume 0.1 cc) will be injected into the uterine cavity with Cook transfer catheter, then the embryo will be transferred with grade A-B cleavage stage. Intervention 2: Control group: in 2-3rd day of mensuration period, after baseline ultrasound, ensuring uterine and ovarian suppression and ovarian pathologies role out, 2 mg estradiol will be started every 12 hours and will be adjusted based on endometrial response. After preparing the endometrium, the thickness of the endometrium reaches the appropriate level by performing serial ultrasound, the participants receives progesterone suppositories for 4 days and 4 minutes before embryo transfer, 0.1 cc of media solution will be injected into the uterine cavity with a Cook transfer catheter and then the embryo will be transferred with grade A-B cleavage step. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Starting 9 months after publication To whom: Only available for people working in academic institutions Conditions: No other condition is considered Where to obtain: hoseinimosa@sina.tums.ac.ir How to obtain: 1 year Comments:
public Dr Sedighe Hoseinimosa
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 8810 hoseinimosa@razi.tums.ac.ir Tehran University of Medical Sciences scientific Dr Sedighe Hoseinimosa
Infertility Department, Shariati Hospital, North Karegar Street, Tehran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8800 8810 hoseinimosa@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 20-39 Embryo with grade A and B First transfer 20 years 39 years Female Age 40 or above 40 Male infertility TESE or PESA and azospermia History of myomectomy Hydrosalphinx Myoma with compressive effect Endometriosis N97 Female infertility Treatment - Drugs Placebo Intervention group: in 2-3rd day of mensuration period, after baseline ultrasound, ensuring uterine and ovarian suppression and ovarian pathologies role out, 2 mg estradiol will be started every 12 hours and will be adjusted based on endometrial response. After preparing the endometrium, the thickness of the endometrium reaches the appropriate level by performing serial ultrasound, the participants receives progesterone suppositories for 4 days and 4 minutes before embryo transfer, 500 units of hCG (volume 0.1 cc) will be injected into the uterine cavity with Cook transfer catheter, then the embryo will be transferred with grade A-B cleavage stage. Control group: in 2-3rd day of mensuration period, after baseline ultrasound, ensuring uterine and ovarian suppression and ovarian pathologies role out, 2 mg estradiol will be started every 12 hours and will be adjusted based on endometrial response. After preparing the endometrium, the thickness of the endometrium reaches the appropriate level by performing serial ultrasound, the participants receives progesterone suppositories for 4 days and 4 minutes before embryo transfer, 0.1 cc of media solution will be injected into the uterine cavity with a Cook transfer catheter and then the embryo will be transferred with grade A-B cleavage step. Pregnancy. Timepoint: 2 weeks after embryos transfer. Method of measurement: Ultrasound. Clinical pregnancy rate. Timepoint: From 12 weeks. Method of measurement: Heart rate presence on ultrasound. Tehran University of Medical Sciences Approved 2021-03-13 Ethics Committee of Tehran University of Medical Sciences Ethics Committee, Tehran University of Medical Sciences, Poorsina Street, Tehran Tehran Tehran Iran (Islamic Republic of)