Effects of Flourish HEC and BioGenesis to Improve Conception

Phase 1

Terminated

• Conditions: Infertility; Infertility Unexplained
• Interventions: Combination Product: Flourish HEC and BioGenesis

• Registration Number: NCT05390606
• Lead Sponsor: Vaginal Biome Science

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.

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Study Start: 2022-06-15
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flourish HEC + BioGenesis arm	Flourish HEC and BioGenesis	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Conception within one year	15 months	Percentage of women becoming pregnant by any method within the 3 month study or within one year after ending the study.
Birthweight at delivery	24 months or fewer	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.
Rate of live birth	24 months or fewer	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.
Gestational age at delivery	24 months or fewer	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.
Rates of pregnancy complications	24 months or fewer	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.

Trial Locations

Locations (1)

Dr. Aimee Eyvazzadeh; 🇺🇸 San Ramon, California, United States