]>
IRCT20120215009014N342 IRCT 2020-03-04 Hamedan University of Medical Sciences Effect of oral contraceptive with gonadotropin-releasing hormone (GnRH) agonist versus Estradiol Valerate on the pregnancy continuity after frozen embryo transfer in infertile women Effect of oral contraceptive with gonadotropin-releasing hormone (GnRH) agonist versus Estradiol Valerate on the pregnancy continuity after frozen embryo transfer in infertile women: a double-blind randomized clinical trial 2019-07-23 anticipated 128 Complete https://irct.ir/trial/46085 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached, Blinding description: The drugs will be given in coded envelopes. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind. 2 Artificial fertilization. Intervention 1: Oral contraceptive pill once daily form the second day of the menstrual cycle for 12 days plus a subcutaneous injection of GnRH agonist 0.5 mg daily from the 15th day of the menstrual cycle for 14 days. Intervention 2: Control group: Estradiol Valerate tablet (manufactured by Abureihan Pharmaceutical Co.) 6 mg twice a day from the second day of the menstrual cycle for at least 10 days. 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 It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Dr Fatemeh Jamshidi
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 fatemejam13655@gmail.com Hamedan University of Medical Sciences scientific Dr. Soghra Rabiri
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 rabieesogol@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 40 years, Infertile women candidate for the embryo transfer process, Having more than 3 embryos for transfer, Having a healthy uterine cavity, Having constant embryo culture medium, Having a constant embryo transfer environment, Having constant fetal quality, Having fixed embryology, 18 years 40 years Female Being a smoker, Idiopathic infertility, Patients with donated oocytes, N98 Complications associated with artificial fertilization Treatment - Drugs Treatment - Drugs Oral contraceptive pill once daily form the second day of the menstrual cycle for 12 days plus a subcutaneous injection of GnRH agonist 0.5 mg daily from the 15th day of the menstrual cycle for 14 days Control group: Estradiol Valerate tablet (manufactured by Abureihan Pharmaceutical Co.) 6 mg twice a day from the second day of the menstrual cycle for at least 10 days Pregnancy continuity after embryo transfer. Timepoint: 12 weeks after the intervention. Method of measurement: With ultrasonography. Ectopic pregnancy. Timepoint: 12 weeks after the intervention. Method of measurement: With ultrasonography. Polygamous pregnancy. Timepoint: 12 weeks after the intervention. Method of measurement: With ultrasonography. Spontaneous abortion. Timepoint: 12 weeks after the intervention. Method of measurement: With ultrasonography. Hamedan University of Medical Sciences Approved 2019-08-20 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)