IUI-PIV trial
- Conditions
- General infertility
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 150
Participants who plan to undergo IUI treatment for any of the following conditions abnormalities in the quantity or quality of sperm/semen, ejaculation disorders or sexual intercourse difficulties, sperm-cervical mucus incompatibility, or functional infertility.
Age of female participants 18 to 43 years old.
Participants who have provided written consent from themselves and their partners.
Individuals who have taken supplements or medications containing similar active ingredients to the investigational drug within 3 months before starting the drug.
Individuals who have taken antibiotics for 5 days or more within 3 months before starting the investigational drug.
Individuals who have participated in other clinical trials (clinical studies) within 3 months before starting the investigational drug that may have led to improvement in vaginal microbiota or other conditions.
Individuals who have experienced diarrhea, vomiting, or allergies to the therapeutic drug.
Individuals deemed unsuitable as study participants by the principal investigator or co-investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Lactobacillus dominance proportion The proportion of increase in Lactobacillus dominance to over 80% after intervention treatment in groups B and C
- Secondary Outcome Measures
Name Time Method Lactobacillus occupancy increase The percentage of patients in Groups B and C whose Lactobacillus occupancy increased to 80% or more after the intervention
Lactobacillus occupancy improvement The percentage of patients whose Lactobacillus occupancy improved after the intervention, by Lactobacillus occupancy
Treatment improvement rate Percentage of cases that improved and those that did not improve (unchanged or worsened) after treatment in Groups B and C
First IUI clinical pregnancy rate Clinical pregnancy rates for the first IUI in groups B and C
First IUI clinical pregnancy rate in improved patients (A vs B) First IUI clinical pregnancy rate in group A and group B patients who improved to LD
First IUI clinical pregnancy rate in improved patients (A vs C) First IUI clinical pregnancy rate among group A and group C patients who improved to LD