Effects of Flourish HEC and BioGenesis to Improve Conception
NCT05390606 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2025-07-01
Summary
This study intends to address whether improving the vaginal microbiome can help couples increase chances of conceiving.
Conditions
- Infertility
- Infertility Unexplained
Interventions
- 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.
Sponsors & Collaborators
-
Vaginal Biome Science
lead OTHER
Principal Investigators
-
Aimee Eyvazzadeh, MD, MS, MBA · Dr. Aimee Eyvazzadeh, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-15
- Primary Completion
- 2023-03-20
- Completion
- 2023-03-20
- FDA Device
- Yes
Countries
- United States
Study Locations
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