Infertility Clinical Trial
Official title:
Pilot Study: Effects of Flourish HEC Vaginal Care System and BioGenesis Fertility Lubricant on Conception
Verified date | July 2023 |
Source | Vaginal Biome Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study intends to address whether improving the vaginal microbiome can help couples increase chances of conceiving.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Dr. Aimee Eyvazzadeh | San Ramon | California |
Lead Sponsor | Collaborator |
---|---|
Vaginal Biome Science | Dr. Aimee Eyvazzadeh, Inc. |
United States,
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 |
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