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IRCT20200905048630N3 IRCT 2021-11-22 Bandare-abbas University of Medical Sciences The effect of serum progesterone on third day after intrauterine insemination (IUI) on pregnancy outcomes in two different methods of progesterone administration Evaluation of serum progesterone level on third day after intrauterine insemination on pregnancy outcomes in two routes of luteal phase support in women with unexplained infertility : A randomized clinical trial study. 2021-08-23 anticipated 140 Complete https://irct.ir/trial/56899 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In order to randomly allocate the samples to each of the study groups, Random allocation software was used, which generated a random sequence using a single block method. The address of the software is as follows: https://random-allocation-software.software.informer.com/2.0/. How to randomize: This software according to the uniform statistical distribution of discrete sequence in the form of letters (or numerical) in the form of ... ABAABAABABBA produces that each letter belongs to a group to hide In order to hide the random allocation so that the assigned group is not known before the individual is assigned, each of the random sequences created is recorded on a card and the cards are placed in the envelopes , respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed. How to use the software by installing the software file and after opening it, first the number of groups is determined, then the sample size of each group and finally the method of numerical or letter randomization is selected in a simple or block form. In this study, the method A block was selected, Blinding description: This research is a one-blind study. Thus, the person analyzing the results is unaware of the status of allocation in groups. R. 3 Infertility. Intervention 1: Intervention group:receiving vaginal progesterone( crinone gel 8%), Crinone gel contains 90 mg of progesterone and is consumed once a day for 14 days. Intervention 2: Control group: receiving Progesterone in the form of Duphaston 10 mg tablets, for 14 days and twice a day. Yes - There is a plan to make this available What will be shared: The data will be presented in the article after analysis When: 2022 To whom: Academic researchers and obstetricians Conditions: Clinical application in patients undergoing IUI Where to obtain: Paper corresponding author How to obtain: E-mail to corresponding author Comments:
public Dr. Maryam azizi kutenaee
Parastar Street
Bandar Abbas Iran (Islamic Republic of) 7916613885 +98 76 3333 0755 maryamazizikut86@gmail.com Bandare-abbas University of Medical Sciences scientific Dr.Maryam azizi kutenaee
Parastar Street
Bandar Abbas Iran (Islamic Republic of) 7916613885 +98 76 3333 0755 maryamazizikut86@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) IUI cycles Patients with normal uterine cavity 18 years 37 years Female Patients with uterine abnormalities such as myoma, anatomical problems, polyp, salpangitis Patients with a history of recurrent miscarriage Age over 37 years old Patients with grade 3 or 4 endometriosis BMI over 30 kg/m2 Previous ectopic pregnancy Usage two type of progesterone for luteal phase support Endometrial thickness lower than 7mm on trigger day Treatment - Drugs Treatment - Drugs Intervention group:receiving vaginal progesterone( crinone gel 8%), Crinone gel contains 90 mg of progesterone and is consumed once a day for 14 days. Control group: receiving Progesterone in the form of Duphaston 10 mg tablets, for 14 days and twice a day Biochemical pregnancy. Timepoint: 14 days after IUI. Method of measurement: Beta serum level evaluation. Biochemical pregnancy. Timepoint: 8 weeks after IUI. Method of measurement: Sonography. Bandare-abbas University of Medical Sciences Approved 2021-06-13 Ethical board of Hormozgan University of Medical Sciences Parastar Street Bandar Abbas Hormozgan Iran (Islamic Republic of)