NCT05390606

Effects of Flourish HEC and BioGenesis to Improve Conception

Pilot Study: Effects of Flourish HEC Vaginal Care System and BioGenesis Fertility Lubricant on Conception

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Vaginal Biome Science · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This study intends to address whether improving the vaginal microbiome can help couples increase chances of conceiving.

Detailed description

Disrupted vaginal microbiomes are associated with a number of poor reproductive outcomes, including infertility, miscarriage, premature rupture of membranes, preterm labor and delivery, delivery of a low birthweight baby, and maternal infections (chorioamnionitis, endometritis). A healthy vaginal microbiome is typically thought to be one that is dominated by one of several Lactobacillus species, such as L. crispatus, L. gasseri, or L. jensenii. Several studies have shown that non-lactobacilli-dominant biomes are associated with poor in vitro fertilization or intrauterine insemination outcomes. Fewer studies have examined fertility in the home setting, and none to date has asked whether improving the vaginal microbiome (VMB) could increase fertility. This study addresses both. By assessing the VMB before and after using a vaginal care system which supports a healthy VMB, we will be able to examine whether there are associations between VMB composition and infertility, and whether shifting the VMB toward a lactobacillus-dominant state is able to improve chances of conception. In this study, women will either follow routine care (control) or routine care plus the vaginal care system and fertility lubricant (intervention) for 3 months or until becoming pregnant, whichever comes first. In addition to tracking conception rates during those 3 months, we will follow women for an additional year following completion of the 3-month timeframe. If any woman is pregnant at the one-year mark, her pregnancy will be followed until delivery (or early termination) to track delivery outcomes and adverse events.

Conditions

• Infertility
• Infertility Unexplained

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Flourish HEC and BioGenesis	Flourish HEC is a 3-component system, including: 1) Balance feminine wash, used daily; 2) BioNourish vaginal moisturizer, used daily before bed except if having intercourse; 3) BiopHresh homeopathic vaginal suppository with probiotics, used once every 3 days before bed except if having intercourse. BioNourish is a class II medical device with FDA 510k clearance, on the market for 2 years. BioGenesis is also a class II medical device with FDA 510k clearance, and is designated as a fertility lubricant, safe for sperm and embryos.

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-03-20
• Completion: 2023-03-20
• First posted: 2022-05-25
• Last updated: 2025-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study