Clinical trial

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

NCT05390606

Name

FRT0322

Description

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

Trial arms

Trial start

2022-06-15

Estimated PCD

2023-03-20

Trial end

2023-03-20

Status

Terminated

Phase

Early phase I

Treatment

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.

Arms:

Flourish HEC + BioGenesis arm

Size

Primary endpoint

Conception at home

3 months

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.

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.

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A longitudinal open label randomized controlled trial.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

Updated at

2023-07-18

1 organization

1 product

2 indications

Organization

Vaginal Biome Science

Product

Flourish HEC and BioGenesis

Indication

infertility

Indication

Infertility Unexplained