Effects of Flourish HEC and BioGenesis to Improve Conception

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05390606
• Other study ID #: FRT0322
• Status: Terminated
• Phase: Phase 1
• Start date: June 15, 2022
• Est. completion date: March 20, 2023

Study information

• Verified date: July 2023
• Source: Vaginal Biome Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility Unexplained

Intervention

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.

Locations

Country	Name	City	State
United States	Dr. Aimee Eyvazzadeh	San Ramon	California

Sponsors (2)

Lead Sponsor	Collaborator
Vaginal Biome Science	Dr. Aimee Eyvazzadeh, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conception at home	Percentage of women becoming pregnant at home within the 3 month study.	3 months
Primary	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.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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