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IRCT20160422027520N21 IRCT 2023-01-24 Tabriz University of Medical Sciences The effect of vaginal probiotic capsule on fertility in women RIF The effect of vaginal probiotic capsule on fertility in women with recurrent implantation failure: Clinical Trial 2023-02-19 anticipated 200 Complete https://irct.ir/trial/67979 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, the sample size of 200 patients with RIF that met our inclusion criteria was considered as the total sample size. 'Random allocation rule' method was used for randomization, where numbers were randomly assigned to cards on a random order of one to 200. Even numbers were assigned to the treatment group and odd numbers to the control group (who did not receive any treatment). In this method, the balance will be reached at the end of the study in the number of people assigned to each group. Each card was placed in sealed and opaque envelopes to hide the random assignment, Blinding description: The participants and the person who analyzed the results were blinded in this study. Participants were aware of the study before being randomized and informed consent was obtained from them. It should be noted that the person analyzing the results had no other role in this study. 2 Recurrent implantation failure. Intervention group: Vaginal probiotic capsule (Three months before embryo transfer, two tablets a day vaginally). Provage vaginal probiotic capsule (Gostaresh Milad Pharmed Co) The ingredients (per one capsule (500 mg)) include Lactobacillus Gasseri 1*0.5 Billion CFU < Lactobacillus Rhamnosus 1*0.5 Billion CFU < Maltodextrin 100 mg.. 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 data
public Mehdi Yousefi
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 4665 mehdi_yusefi@yahoo.com Tabriz University of Medical Sciences scientific Mehdi Yousefi
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614766 0 mehdi_yusefi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients from East Azerbaijan Having at least three implantation failures after IVF/ICSI Having primary infertility The thickness of the endometrium on the day of ovulation induction with HCG should be less than 6 mm Having regular menstrual cycles BMI under 30 Do not have any type of immunotherapy in their medical history. 18 years 40 years Female Patients under 18 years old and over 41 years old Having polycystic ovarian syndrome Poor ovarian reserve Having chromosomal abnormalities Positive HIV, HCV or HBV tests Patients with intrauterine anomalies. Patients with coagulation problems. N98.9 Complication associated with artificial fertilization, unspecified Treatment - Drugs Intervention group: Vaginal probiotic capsule (Three months before embryo transfer, two tablets a day vaginally). Provage vaginal probiotic capsule (Gostaresh Milad Pharmed Co) The ingredients (per one capsule (500 mg)) include Lactobacillus Gasseri 1*0.5 Billion CFU < Lactobacillus Rhamnosus 1*0.5 Billion CFU < Maltodextrin 100 mg. Pregnancy rate. Timepoint: After positive beta-hCG test, clinical pregnancy was evaluated at 5-6 week. Method of measurement: Examining the formation of gestational sac using Sonography method. Live birth rate. Timepoint: 9 months. Method of measurement: People with positive β-hCG test after treatment will be continuously monitored with the help of gynecologists. After about 9 months, we will evaluate the number of babies born. Tabriz University of Medical Sciences Approved 2022-12-05 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences , Daneshghah st, Tabriz, Tabriz East Azarbaijan Iran (Islamic Republic of)