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IRCT20110301005942N8 IRCT 2021-11-15 Tabriz University of Medical Sciences Comparison of sildenafil and isorbid effects on embery transfer outcome in patients with recurrent implantation failure Comparison of sildenafil and isorbid effects on embery transfer outcome in patients with recurrent implantation failure 2021-08-29 anticipated 90 Complete https://irct.ir/trial/58453 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, there will be two intervention groups. Assignment of patients to study groups after their arrival will be done using closed letter envelopes with numbers 1 to the maximum sample size on the envelopes and AB groups in the envelopes and written in them and mixed randomly. . After the package is selected by the patient recipient, patients will be divided into desired groups, Blinding description: The facilitator (supervisor) who is not involved in the collection and analysis of study data will be aware of the study groupings and the researcher, the data collector and the data analyzer will be blinded to the study groups. The subjects will not be aware of their behaviors during treatment. Patients will be assigned to study groups after their arrival using closed letter envelopes with numbers 1 to 90 on the envelopes and groups A and B written on the envelopes and mixed randomly. After the package is selected by the patient recipient, patients will be divided into desired groups. Envelopes will be arranged by the facilitator (supervisor) and study groups will be selected. Envelopes will be selected by the female resident. Envelopes will be numbered from number 1 to the end. The first person will be given the first envelope and this will continue until the last desired number, where 45 people will be in group A and 45 people in group B. 2 Infertility. Intervention 1: Intervention group 1: Intervention group 1. For patients on day 1-3 of the menstrual cycle, vaginal ultrasound is performed and in the absence of ovarian cysts and space-occupying lesions in the uterine cavity, the standard treatment required for endometrial preparation is started. Endometrial preparation with 4 mg estradiol valerate tablets The gram starts and increases to 6 mg per day after 3 days. In the first group, at the same time as estradiol sildenafil is started, 50 mg daily is administered vaginally and fetal transfer is continued until the day before. Intervention 2: Intervention group 2: For patients on day 1-3 of the menstrual cycle, vaginal ultrasound is performed and in the absence of ovarian cysts and space-occupying lesions in the uterine cavity, the standard treatment required for endometrial preparation is started. Endometrial preparation begins with estradiol valerate tablets at a dose of 4 mg and increases to 6 mg per day after 3 days. In the second group, in addition to standard treatment, the administration of isosorbide dinitrate 10 mg vaginal tablets is started from the day of estradiol onset and continues until one day before embryo transfer. The initial ultrasound control for endometrial thickness is performed 10 days later. 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 There is no more information.
public Dr. Aliye Ghasemzadeh
Golgasht Street, Tabriz University Of Medical Sciences
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3557 1113 alghasemzadeh@yahoo.co.uk Tabriz University of Medical Sciences scientific Dr.Aliye Ghasemzadeh
Golgasht Street ,Tabriz University Of Medical Sciences
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3553 9161 alghasemzadeh@yahoo.co.uk Tabriz University Of Medical Sciences Iran (Islamic Republic of) 15 to 40 years Patients with a history of double implantation failure who have at least 2 frozen embryos for transfer will be included in the study with consent. 15 years 40 years Female 1.Treatment with hypertension drugs 2.Myoma, adenomyosis, congenital malformations of the uterus, endometriosis 3.History of cardiovascular or renal or liver disease or use of nonsteroidal anti-inflammatory drugs and any chronic disease Reluctance to participate in the study N97.1 Female infertility of tubal origin Treatment - Drugs Treatment - Drugs Intervention group 1: Intervention group 1. For patients on day 1-3 of the menstrual cycle, vaginal ultrasound is performed and in the absence of ovarian cysts and space-occupying lesions in the uterine cavity, the standard treatment required for endometrial preparation is started. Endometrial preparation with 4 mg estradiol valerate tablets The gram starts and increases to 6 mg per day after 3 days. In the first group, at the same time as estradiol sildenafil is started, 50 mg daily is administered vaginally and fetal transfer is continued until the day before. Intervention group 2: For patients on day 1-3 of the menstrual cycle, vaginal ultrasound is performed and in the absence of ovarian cysts and space-occupying lesions in the uterine cavity, the standard treatment required for endometrial preparation is started. Endometrial preparation begins with estradiol valerate tablets at a dose of 4 mg and increases to 6 mg per day after 3 days. In the second group, in addition to standard treatment, the administration of isosorbide dinitrate 10 mg vaginal tablets is started from the day of estradiol onset and continues until one day before embryo transfer. The initial ultrasound control for endometrial thickness is performed 10 days later. Evaluation of endometrial thickness. Timepoint: The initial evaluation of endometrial thickness is performed on day 1 to 3 and then 10 days later. Method of measurement: Trans vaginal sonograghy. BHCG titer examination. Timepoint: Chemical pregnancy 2 weeks after embryo transfer. Method of measurement: Chemical pregnancy with BHCG. Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: Trans vaginal sonography. Tabriz University of Medical Sciences Approved 2021-08-29 Ethics Committee Of Tabriz University Of Medical Sciences. Third Floor, Central Building of Number2, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)