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Probiotic

Flourish HEC and BioGenesis for Infertility

Phase 1
Waitlist Available
Led By Aimee Eyvazzadeh, MD, MS, MBA
Research Sponsored by Sexual Health and Wellness Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months or fewer
Awards & highlights

Study Summary

This trial will test whether improving the vaginal microbiome can help couples increase their chances of conceiving.

Eligible Conditions
  • Infertility
  • Unexplained Infertility

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months or fewer
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months or fewer for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in vaginal microbiome
Change in vaginal pH
Conception at home
Secondary outcome measures
Birthweight at delivery
Conception within one year
Gestational age at delivery
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Flourish HEC + BioGenesis armExperimental Treatment1 Intervention
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.
Group II: Control armActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Sexual Health and Wellness InstituteLead Sponsor
8 Previous Clinical Trials
173 Total Patients Enrolled
Vaginal Biome ScienceLead Sponsor
8 Previous Clinical Trials
173 Total Patients Enrolled
Dr. Aimee Eyvazzadeh, Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to join this clinical trial?

"This research seeks 40 participants between the ages 18 and 40, who are trying to conceive in a cisgender relationship. Additionally, they must be attending fertility clinics."

Answered by AI

Is the opportunity for participation in this study currently available?

"Clinicaltrials.gov shows that this experiment is no longer enrolling patients, despite initially being posted on June 15th 2022 and last updated 28 days later. However, there are currently 249 other clinical trials actively seeking participants for their studies."

Answered by AI

Have Flourish HEC and BioGenesis achieved regulatory authorization from the FDA?

"Due to the limited data supporting safety and efficacy, our team at Power has assigned a score of 1 for Flourish HEC and BioGenesis when evaluating their safety."

Answered by AI

What are the main goals of this medical research project?

"The purpose of the study is to measure outcomes from baseline until either three months have passed or conception occurs, whichever comes first. Primary goals include successful home conceiving while secondary objectives account for rates of live birth, gestational age at delivery, and pregnancy complications within one year post-study."

Answered by AI

Does this research program accept participants of a specific age or younger?

"According to the prerequisites of this trial, those hoping to be enrolled must fall between 18 and 40 years old."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~0 spots leftby Apr 2025