Health Condition 1: E638- Other specified nutritional deficiencies
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: NIL: NIL
Sponsors
MicrobioTx Health Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: For Infertility group - Married female patients of reproductive age group having an active married life (regular unprotected intercourse, minimum of 12 months) and with a complaint of being unable to conceive for 1 year. For the control group - females with a history of at least 1 spontaneous conception and no current history of infertility
Exclusion criteria
Exclusion criteria: Participants with a history of alcohol consumption exceeding 20 grams per day Participants taking immunosuppressants, tamoxifen, amiodarone and/or perhexiline; Participants who have taken antibiotics in the last 3 weeks Current use of vaginal creams or pessary Inability to conceive due to male infertility Active genital or gastrointestinal infection Any active illness, psychological and/or pathological condition or chronic disease that would interfere with study participation in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of Vaginal Microbiome Test Accuracy is defined as : (True Positive + True Negative)/(True Positive + True Negative + False Positive + False negative) Where True Positive: Microbe present in NGS and predicted by VMT within a 95% Confidence Interval (CI) of the NGS abundance value True Negative: Microbe absent in NGS and predicted by VMT within 95% CI of NGS abundance value (i.e., 0) False Positive: Microbe absent in NGS but predicted by VMT outside 95% CI of NGS abundance value False Negative: Microbe present in NGS but predicted by VMT within 95% CI of abundance value of 0Timepoint: The single time point at which the data will be analysed will be 52 weeks from the start of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Design probiotic formulation to improve oral microbial healthTimepoint: The single time point at which the data will be analysed will be 1.5 year from the start of the study. | — |
Countries
India
Contacts
Public ContactDr Palok Aich
MicrobioTx Health Private Limited
Outcome results
None listed