Effects of Flourish HEC and BioGenesis to Improve Conception

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

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

Study Overview

• Status: Terminated
• Conditions: Infertility; Infertility Unexplained
• Intervention / Treatment: Combination product: Flourish HEC and BioGenesis

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Ramon, California, United States, 94583
      • Dr. Aimee Eyvazzadeh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conception at home	Percentage of women becoming pregnant at home within the 3 month study.	3 months
Change in vaginal microbiome	Vaginal microbiome composition tested by next-generation sequencing	Baseline to end of active study period, which is either at 3 months or upon confirmation of pregnancy, whichever occurs first.
Change in vaginal pH	Vaginal pH tested by vaginal fluid applied to pH test strip	Baseline to end of active study period, which is either at 3 months or upon confirmation of pregnancy, whichever occurs first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conception within one year	Percentage of women becoming pregnant by any method within the 3 month study or within one year after ending the study.	15 months
Rate of live birth	Percentage of women giving live birth within one year after ending the study; or if pregnant at one year, following to the end of her pregnancy.	24 months or fewer
Gestational age at delivery	Average gestational age of babies born within one year after ending the study; or if mothers are pregnant at one year, following to the end of her pregnancy.	24 months or fewer
Birthweight at delivery	Average weight of babies born within one year after ending the study; or if mothers are pregnant at one year, following to the end of her pregnancy.	24 months or fewer
Rates of pregnancy complications	Percentage of women experiencing complications (including preeclampsia, miscarriage/fetal loss/stillbirth, preterm/premature rupture of membranes, chorioamnionitis or endometritis, gestational diabetes, and any other adverse outcome) within one year after ending the study; or if mothers are pregnant at one year, following to the end of her pregnancy.	24 months or fewer

Collaborators and Investigators

• Sponsor: Vaginal Biome Science
• Collaborators: Dr. Aimee Eyvazzadeh, Inc.
• Investigators: Principal Investigator: Aimee Eyvazzadeh, MD, MS, MBA, Dr. Aimee Eyvazzadeh, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: FRT0322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No