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IRCT20230803059016N1 IRCT 2023-08-21 Tehran University of Medical Sciences Investigating the effect of intrauterine injection of human chorionic gonadotropin (hCG) on pregnancy outcomes in the transfer of fresh embryos in cycles related to assisted reproductive technology (ART) Investigating the effect of intrauterine injection of human chorionic gonadotropin (hCG) on pregnancy outcomes in the transfer of fresh embryos in cycles related to assisted reproductive technology (ART) 2023-08-27 anticipated 158 Complete https://irct.ir/trial/71801 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 158 patients will be randomly divided into two intervention groups (79 patients, HCG injection) and a placebo group (79 patients, standard treatment) by assigning three-digit codes by Random Allocation Software (RAS). Allocation concealment is used for concealment. This is done using opaque sealed envelopes in a random sequence (numbered, sealed, opaque envelopes). In this method, each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lids of the envelopes are glued and put in the box. At the time of registration of the participants, based on the order of arrival of the eligible participants, the envelopes will be opened and the assigned group of that participant will be determined, Blinding description: The blinding of this study will be single-blind and the patients will not be informed about the placement of individuals in the study groups. 3 Pregnancy. Intervention 1: Intervention group: After the completion of puncture, on the day of transfer of a fresh embryo with A-B cleavage stage, injection of 500 units of hCG (volume 0.1 cc, manufactured by Aburihan company) into the uterus with a cook transfer catheter, daily reception of one progesterone suppository every 12 hours (manufactured by Aburihan company) for 2 weeks, daily injection of one progesterone ampoule for 2 weeks (manufactured by Aburihan company), checking serum beta-hCG level two weeks after the initial injection of hCG to evaluate the positive or negative pregnancy, vaginal ultrasound and observation of the patient's gestational sac 2 weeks after the positive pregnancy test (4 weeks after the initial hCG injection). Intervention 2: Control group: After the completion of puncture, on the day of transfer of a fresh embryo with A-B cleavage stage, injection of 500 units of hCG (volume 0.1 cc, manufactured by Aburihan company) into the uterus with a cook transfer catheter, daily reception of one progesterone suppository every 12 hours (manufactured by Aburihan company) for 2 weeks, daily injection of one progesterone ampoule for 2 weeks (manufactured by Aburihan company), checking serum beta-hCG level two weeks after the initial injection of hCG to evaluate the positive or negative pregnancy, vaginal ultrasound and observation of the patient's gestational sac 2 weeks after the positive pregnancy test (4 weeks after the initial the peripheral solution). No - There is not a plan to make this available Justification or reason for not sharing IPD is The person's information will be confidential and the results will be as collective statistics.
public Behareh Ghahroudizadeh Abianeh
Shariati hospital, in front of the Faculty of Economics, North Kargar St., Jalal Al-Ahmed Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 drghahroudi@gmail.com Tehran University of Medical Sciences scientific Sedigheh Hosseinimousa
Shariati hospital, in front of the Faculty of Economics, North Kargar St., Jalal Al-Ahmed Street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 sedighehoseinimosa@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age 20 to 39 years old Embryos with A and B quality and fresh embryo transfer 20 years 39 years Female Transfer of frozen embryo Male infertility History of myomectomy Presence of hydrosalpinx Presence of fibroids with pressure effect on endometrium and endometriosis. Age more than 40 years Pregnancy O00-O08 Treatment - Drugs Placebo Intervention group: After the completion of puncture, on the day of transfer of a fresh embryo with A-B cleavage stage, injection of 500 units of hCG (volume 0.1 cc, manufactured by Aburihan company) into the uterus with a cook transfer catheter, daily reception of one progesterone suppository every 12 hours (manufactured by Aburihan company) for 2 weeks, daily injection of one progesterone ampoule for 2 weeks (manufactured by Aburihan company), checking serum beta-hCG level two weeks after the initial injection of hCG to evaluate the positive or negative pregnancy, vaginal ultrasound and observation of the patient's gestational sac 2 weeks after the positive pregnancy test (4 weeks after the initial hCG injection). Control group: After the completion of puncture, on the day of transfer of a fresh embryo with A-B cleavage stage, injection of 500 units of hCG (volume 0.1 cc, manufactured by Aburihan company) into the uterus with a cook transfer catheter, daily reception of one progesterone suppository every 12 hours (manufactured by Aburihan company) for 2 weeks, daily injection of one progesterone ampoule for 2 weeks (manufactured by Aburihan company), checking serum beta-hCG level two weeks after the initial injection of hCG to evaluate the positive or negative pregnancy, vaginal ultrasound and observation of the patient's gestational sac 2 weeks after the positive pregnancy test (4 weeks after the initial the peripheral solution). Embryo implantation rate. Timepoint: Before and after the intervention. Method of measurement: Vaginal ultrasound. Clinical pregnancy rate. Timepoint: Before and after the intervention. Method of measurement: Vaginal ultrasound. Abortion rate MR. Timepoint: Before and after the intervention. Method of measurement: Vaginal ultrasound. Ongoing pregnancy rate (OPR ). Timepoint: Before and after the intervention. Method of measurement: Vaginal ultrasound. Tehran University of Medical Sciences Approved 2023-06-26 Ethics committee of Tehran University of Medical Sciences 6th floor of Research and Technology Deputy, Central Organization of the University, corner of Quds St, Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)