Clinical trial NCT05390606: Effects of Flourish HEC and BioGenesis to Improve Conception
Official title: Pilot Study: Effects of Flourish HEC Vaginal Care System and BioGenesis Fertility Lubricant on Conception
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Infertility
Infertility Unexplained
Lead sponsor: Vaginal Biome Science
Sponsor class: OTHER
Collaborators: name: Dr. Aimee Eyvazzadeh, Inc.
First posted: 2022-05-25
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A longitudinal open label randomized controlled trial.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Conception at home
timeFrame: 3 months
measure: Change in vaginal microbiome
timeFrame: Baseline to end of active study period, which is either at 3 months or upon confirmation of pregnancy, whichever occurs first.
measure: Change in vaginal pH
timeFrame: Baseline to end of active study period, which is either at 3 months or upon confirmation of pregnancy, whichever occurs first.
Secondary outcomes:
measure: Conception within one year
timeFrame: 15 months
measure: Rate of live birth
timeFrame: 24 months or fewer
measure: Gestational age at delivery
timeFrame: 24 months or fewer
measure: Birthweight at delivery
timeFrame: 24 months or fewer
measure: Rates of pregnancy complications
timeFrame: 24 months or fewer
Other outcomes:
Locations:
city: San Ramon
country: United States
facility: Dr. Aimee Eyvazzadeh
state: California
Study officials:
affiliation: Dr. Aimee Eyvazzadeh, Inc.
name: Aimee Eyvazzadeh, MD, MS, MBA
role: PRINCIPAL_INVESTIGATOR
References: