Infertility of unknown cause. Female infertility, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Infertile women with unknown cause consuming the probiotic Biofem Tekgene Pharma is a specific probiotic for women. Biofem is an oral supplement. (It is not vaginal
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Age range 18 to 35 years 2. BMI=24.9=18.5 3. Regular menstrual cycles Normal color graph of the fallopian tubes Normal Spermogram DFI less than 15 for sperm Normal hormonal profile Minimum number of antral follicles per ovary: 5
Exclusion criteria
Exclusion criteria: 1. Underlying medical conditions such as a history of cardiovascular disease, high blood pressure, diabetes, endometriosis 2. Thromboembolism or history of any systemic disease 3. Congenital or acquired structural uterine disorders such as uterine fibroids, adenomyosis, uterine polyps, and Müllerian anomalies 4. History of recurrent miscarriage 5. Smoking or alcohol consumption 6. History of hormonal medication use in the past 3 months 7. Active genital infections 8. Genetic disorders in couples 9. Hydrosalpinx 10. Endocrine disorders 11. History of ovarian tumor surgery 12. Metabolic syndrome 13. History of pelvic surgery Autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of infertility with unknown cause. Timepoint: Measurement of study variables 45 days after consuming Biofem capsules and on the day of egg puncture. Method of measurement: pregnancy rate using blood test (human chorionic gonadotropin)BHCG.;Proteins affecting egg quality. Timepoint: Measurement of study variables 45 days after consuming Biofem capsules and on the day of egg puncture. Method of measurement: Gene measurement using Western blot, evaluation of oocyte and embryo morphology using inverted microscope.;"The effect of Biofm capsules on oxidative stress and total antioxidant capacity. Timepoint: Measurement of study variables 45 days after consuming Biofem capsules and on the day of egg puncture. Method of measurement: Measurement of oxidative stress and total antioxidant capacity using ELISA (continuous immunoassay).;The amount of Lactobacillus and Bifidium microbiota in follicular fluid. Timepoint: Measurement of study variables 45 days after consuming Biofem capsules and on the day of egg puncture. Method of measurement: Measurement of microbiota in follicular fluid using real-time PCR (polymerase chain reaction) method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Checking the pregnancy rate. Timepoint: 14 days after embryo transfer, or in other words, 45 days from the start of Biofem use at the beginning of the cycle.(Actually, they use Biofm 45 days before ovulation). Method of measurement: Measurement of oxidative stress and total antioxidant capacity using ELISA (continuous immunosorbent assay), measurement of microbiota in follicular fluid using real-time PCR (polymerase chain reaction), measurement of genes using Western blot, evaluation of oocyte and embryo morphology using inverted microscope,. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNaghmeh Shahbaztabari
Iran University of Medical Sciences
Outcome results
None listed