Pilot Study: Effects of Flourish HEC Vaginal Care System and BioGenesis Fertility Lubricant on Conception
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Conception at home
研究概览
简要总结
This study intends to address whether improving the vaginal microbiome can help couples increase chances of conceiving.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women part of a cisgender couple aged 18 to 40 who are attempting to become pregnant and are attending a fertility clinic.
排除标准
- •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
- •Any diagnosis that would require the participant to undergo in vitro fertilization to become pregnant
- •Known allergies to any component of BioNourish®, Balance, BiopHresh®, or BioGenesis™
- •Known active vaginal infection at enrollment
结局指标
主要结局
Conception at home
时间窗: 3 months
Percentage of women becoming pregnant at home within the 3 month study.
Change in vaginal microbiome
时间窗: 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
时间窗: 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
次要结局
- Conception within one year(15 months)
- Birthweight at delivery(24 months or fewer)
- Rate of live birth(24 months or fewer)
- Gestational age at delivery(24 months or fewer)
- Rates of pregnancy complications(24 months or fewer)