Effects of Flourish HEC and BioGenesis to Improve Conception

NCT ID: NCT05390606

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-03-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control arm

Women follow routine care only, including prescribed medications and recommended techniques and supplements for attempting to become pregnant at home for up to three months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Flourish HEC + BioGenesis arm

In addition to routine care followed by women in control arm, women in this arm also use the Flourish HEC (Hydroxyethylcellulose) vaginal care system and BioGenesis fertility lubricant for up to three months.

Group Type: EXPERIMENTAL

Flourish HEC and BioGenesis

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

Women part of a cisgender couple aged 18 to 40 who are attempting to become pregnant and are attending a fertility clinic.

Exclusion Criteria

1. Pregnant

2. Lactating

3. Severe male factor, hormonal imbalance (oligoovulatory/anovulatory cycles, cycles longer than 35 days), genetic abnormalities (chromosomal abnormality, common genetic mutation between partners), or severe uterine or tubal factor

4. Any diagnosis that would require the participant to undergo in vitro fertilization to become pregnant

5. Known allergies to any component of BioNourish®, Balance, BiopHresh®, or BioGenesis™

6. Known active vaginal infection at enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vaginal Biome Science

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aimee Eyvazzadeh, MD, MS, MBA

Role: PRINCIPAL_INVESTIGATOR

Dr. Aimee Eyvazzadeh, Inc.

Locations

Dr. Aimee Eyvazzadeh

San Ramon, California, United States

Countries

United States

Other Identifiers

FRT0322

Identifier Type: -

Identifier Source: org_study_id