Effects of Flourish HEC and BioGenesis to Improve Conception

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

Detailed Description
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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.

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

Conditions
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Infertility Unexplained, Infertility

Intervention / Treatment
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* Combination Product: Flourish HEC and BioGenesis


Participation Criteria
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Eligibility Criteria
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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: Pregnant Lactating 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 Any diagnosis that would require the participant to undergo in vitro fertilization to become pregnant Known allergies to any component of BioNourish®, Balance, BiopHresh®, or BioGenesis™ Known active vaginal infection at enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A longitudinal open label randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 |