]>
IRCT20181030041503N2 IRCT 2020-03-05 Mashhad University of Medical Sciences Effect of intrauterine injection of chorionic gonadotropin hormon before transfer of fresh and freezee mbryo on outcome of IVF Effect of intrauterine injection of chorionic gonadotropin hormon before transfer of fresh and freezee mbryo on outcome of IVF and ICSI 2020-02-04 anticipated 416 Complete https://irct.ir/trial/46104 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation blocks will be used to assign treatment to the two groups, in which the new transfer group will specify the control group with the letter a and the intervention group with the letter b, each block size 4, the number of blocks 26 and the number of permutations. There are 4 possible cases. Then random number table] or using simulation software in runif (26, min = 1, max = 4) [R, select 26 random numbers and fill 26 blocks of states. The same goes for the Freeze groupgroups, Blinding description: Patient is unaware of treatment - doctor who performing transfer not aware of fluid that injected into uterus .Fluid delivered to physician based on randomized list - Analysistt not aware of treatment. N/A Feresh and freeze transfer after intrautrine HCG injection. Intervention 1: Intervention group:Intervention group: In the fresh transfer group based on age and patient diagnosis, three protocols for IVF preparation are used. In the long-acting GnRH agonist method, 500 micrograms of subcutaneous GnRH analogue (buserelin, supernatant) is started on day 21 of the preceding cycle and is reduced to 200 micrograms from the second day of the analogue dose cycle. In the micro-dose method, the supernatant begins the second day of the cycle. Starts. In the long-term GnRH agonist method after providing ovarian suppression according to the ultrasound view, and in other protocols, from the second or third day of the recombinant gonadotropin cycle (puregon, organon, Netherland, gonl, Merck-, Europe, ltd). , uk (serono starts)The starting dose of gonadotropins is determined by the patient's age, previous cycle, ovarian reserve. 5 days after stimulation with gonadotropins, the first ovarian monitoring is performed by ultrasound and dose adjusted as needed. HMG is added when Lh is required. When at least three follicles reach 17 mm, 10,000 units of HCG are prescribed. 36 hours after HCG administration, ovulation is performed under general anesthesia. The oocytes obtained were maintained in Cleave medium (Origio-Denmark) at 37 ° C with 26% Co and 5% o 2 and then the cumulus cells were removed around the oocyte, Finally, intracytoplasmic sperm injection is performed. Embryos are cultured in successive media. The embryos are examined daily for quality. Each blast or clavage of one or two embryos of high quality A or B is frozen to transfer selection and the other embryos are frozen.in freeze transfer group Preparation Of endometrium is performed with one of the three ;hormone therapy protocols, natural or ovarian stimulation depending on each patient's condition. Preparation of hcg for intrauterine injection prior to transfer IN BOTH intervention group is performed by adding 500 IuHCG with 40 µl of media (origio.Denmark).and Before transfER injected to uterine., after 4 minutes of one or two embryo transfer with one or using a Cook (Australia) catheter and abdominal sonography. 600 mg urethrgestan for luteal phase support (utrogestan, Besins, Brussels, Belgium) is given daily vaginally. BHCG is measured 14 days after transfer. Chemical pregnancy The appearance of BHCG in the blood is 2 weeks after clinical transfusions at 6 weeks of gestation . ongoing pregnancy is continued for up to 12 weeks. Intervention 2: Intervention group:Intervention group: In the fresh transfer group based on age and patient diagnosis, three protocols for IVF preparation are used. In the long-acting GnRH agonist method, 500 micrograms of subcutaneous GnRH analogue (buserelin, supernatant) is started on day 21 of the preceding cycle and is reduced to 200 micrograms from the second day of the analogue dose cycle. In the micro-dose method, the supernatant begins the second day of the cycle. Starts. In the long-term GnRH agonist method after providing ovarian suppression according to the ultrasound view, and in other protocols, from the second or third day of the recombinant gonadotropin cycle (puregon, organon, Netherland, gonl, Merck-, Europe, ltd). , uk (serono starts)The starting dose of gonadotropins is determined by the patient's age, previous cycle, ovarian reserve. 5 days after stimulation with gonadotropins, the first ovarian monitoring is performed by ultrasound and dose adjusted as needed. HMG is added when Lh is required. When at least three follicles reach 17 mm, 10,000 units of HCG are prescribed. 36 hours after HCG administration, ovulation is performed under general anesthesia. The oocytes obtained were maintained in Cleave medium (Origio-Denmark) at 37 ° C with 26% Co and 5% o 2 and then the cumulus cells were removed around the oocyte, Finally, intracytoplasmic sperm injection is performed. Embryos are cultured in successive media. The embryos are examined daily for quality. Each blast or clavage of one or two embryos of high quality A or B is frozen to transfer selection and the other embryos are frozen.in freeze transfer group Preparation Of endometrium is performed with one of the three ;hormone therapy protocols, natural or ovarian stimulation depending on each patient's condition. Preparation of hcg for intrauterine injection prior to transfer IN BOTH intervention group is performed by adding 40 µl normalsalin as plasebo Before transfER injected to uterine., after 4 minutes of one or two embryo transfer with one or using a Cook (Australia) catheter and abdominal sonography. 600 mg urethrgestan for luteal phase support (utrogestan, Besins, Brussels, Belgium) is given daily vaginally. BHCG is measured 14 days after transfer. Chemical pregnancy The appearance of BHCG in the blood is 2 weeks after clinical transfusions at 6 weeks of gestation . ongoing pregnancy is continued for up to 12 weeks. 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 I am reviewing the subject
public Malihe Mahmoudinia
Milad Fertility Clinic, East Razi Street, Dah e Day Square,
Mashhad Iran (Islamic Republic of) 9178631973 +98 51 3853 4021 MahmoudiniaM@mums.ac.ir Mashhad University of Medical Sciences scientific Nayyereh khadem
Emam Reza Hospital, Ebne Sina Street
Mashhad Iran (Islamic Republic of) 9178631973 +98 51 3801 2607 khademn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age 18-42 years A history of infertility for unknown reasons or male factor Indication for IVF 18 years 42 years Female SEVER OLIGOSPERMIA Uterine abnormality Uterine Surgery History N98.3 Complications of attempted introduction of embryo in embryo transfer Treatment - Other Treatment - Other Intervention group:Intervention group: In the fresh transfer group based on age and patient diagnosis, three protocols for IVF preparation are used. In the long-acting GnRH agonist method, 500 micrograms of subcutaneous GnRH analogue (buserelin, supernatant) is started on day 21 of the preceding cycle and is reduced to 200 micrograms from the second day of the analogue dose cycle. In the micro-dose method, the supernatant begins the second day of the cycle. Starts. In the long-term GnRH agonist method after providing ovarian suppression according to the ultrasound view, and in other protocols, from the second or third day of the recombinant gonadotropin cycle (puregon, organon, Netherland, gonl, Merck-, Europe, ltd). , uk (serono starts)The starting dose of gonadotropins is determined by the patient's age, previous cycle, ovarian reserve. 5 days after stimulation with gonadotropins, the first ovarian monitoring is performed by ultrasound and dose adjusted as needed. HMG is added when Lh is required. When at least three follicles reach 17 mm, 10,000 units of HCG are prescribed. 36 hours after HCG administration, ovulation is performed under general anesthesia. The oocytes obtained were maintained in Cleave medium (Origio-Denmark) at 37 ° C with 26% Co and 5% o 2 and then the cumulus cells were removed around the oocyte, Finally, intracytoplasmic sperm injection is performed. Embryos are cultured in successive media. The embryos are examined daily for quality. Each blast or clavage of one or two embryos of high quality A or B is frozen to transfer selection and the other embryos are frozen.in freeze transfer group Preparation Of endometrium is performed with one of the three ;hormone therapy protocols, natural or ovarian stimulation depending on each patient's condition. Preparation of hcg for intrauterine injection prior to transfer IN BOTH intervention group is performed by adding 500 IuHCG with 40 µl of media (origio.Denmark).and Before transfER injected to uterine., after 4 minutes of one or two embryo transfer with one or using a Cook (Australia) catheter and abdominal sonography. 600 mg urethrgestan for luteal phase support (utrogestan, Besins, Brussels, Belgium) is given daily vaginally. BHCG is measured 14 days after transfer. Chemical pregnancy The appearance of BHCG in the blood is 2 weeks after clinical transfusions at 6 weeks of gestation . ongoing pregnancy is continued for up to 12 weeks. Intervention group:Intervention group: In the fresh transfer group based on age and patient diagnosis, three protocols for IVF preparation are used. In the long-acting GnRH agonist method, 500 micrograms of subcutaneous GnRH analogue (buserelin, supernatant) is started on day 21 of the preceding cycle and is reduced to 200 micrograms from the second day of the analogue dose cycle. In the micro-dose method, the supernatant begins the second day of the cycle. Starts. In the long-term GnRH agonist method after providing ovarian suppression according to the ultrasound view, and in other protocols, from the second or third day of the recombinant gonadotropin cycle (puregon, organon, Netherland, gonl, Merck-, Europe, ltd). , uk (serono starts)The starting dose of gonadotropins is determined by the patient's age, previous cycle, ovarian reserve. 5 days after stimulation with gonadotropins, the first ovarian monitoring is performed by ultrasound and dose adjusted as needed. HMG is added when Lh is required. When at least three follicles reach 17 mm, 10,000 units of HCG are prescribed. 36 hours after HCG administration, ovulation is performed under general anesthesia. The oocytes obtained were maintained in Cleave medium (Origio-Denmark) at 37 ° C with 26% Co and 5% o 2 and then the cumulus cells were removed around the oocyte, Finally, intracytoplasmic sperm injection is performed. Embryos are cultured in successive media. The embryos are examined daily for quality. Each blast or clavage of one or two embryos of high quality A or B is frozen to transfer selection and the other embryos are frozen.in freeze transfer group Preparation Of endometrium is performed with one of the three ;hormone therapy protocols, natural or ovarian stimulation depending on each patient's condition. Preparation of hcg for intrauterine injection prior to transfer IN BOTH intervention group is performed by adding 40 µl normalsalin as plasebo Before transfER injected to uterine., after 4 minutes of one or two embryo transfer with one or using a Cook (Australia) catheter and abdominal sonography. 600 mg urethrgestan for luteal phase support (utrogestan, Besins, Brussels, Belgium) is given daily vaginally. BHCG is measured 14 days after transfer. Chemical pregnancy The appearance of BHCG in the blood is 2 weeks after clinical transfusions at 6 weeks of gestation . ongoing pregnancy is continued for up to 12 weeks. Chemical pregnancy rate. Timepoint: 2weeks after embryo transfer. Method of measurement: βHCG test. Clinical pregnancy rate. Timepoint: 6 week after embryo transfer. Method of measurement: sonography. Ongoing pregnancy. Timepoint: Continued pregnancy up to 12. Method of measurement: Trans vaginal Sonography. Mashhad University of Medical Sciences Approved 2019-12-05 Mashhad university of Medical sciences Ethics committee Vice Chancellor Of Research,Mashhad University of Medical Sciences ,Mashhad University of Medical Sciences,University Avenue ,Mashhad mashhad Razavi Khorasan Iran (Islamic Republic of)