The effect of vaginal probiotic capsule on fertility in women with recurrent implantation failure: Clinical Trial

Determining the effect of using vaginal probiotic capsules on fertility in women with recurrent implantation failure (RIF)

Written and informed consent will be obtained from people with RIF who are our target population in this project (200 people in each group). This product will be used vaginally three months before embryo transfer twice a day.

The study will be conducted in Valiasr International Hospital, Tabriz. Study subjects will receive probiotic pills according to the protocol. Pregnancy and clinical pregnancy rate will be evaluated. Finally, the number of babies born to affected individuals will be evaluated and compared with the control group that did not receive any treatment.

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.

Subjects will receive probiotic tablets (Provage vaginal probiotic capsule (Gostaresh Milad Pharmed Co)) according to the protocol. 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. This product will be used three months before embryo transfer twice a day to restore and maintain the health of the vaginal flora by improving its pH level.

1- Pregnancy rate by serum β-hCG protein measurement and based on the gestational sac view and ultrasound at 6 or 7 weeks of pregnancy. 2- The number of babies born by the affected patients in compared with the control group that received no treatment.

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.

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.