Probiotic and Antibiotic Therapies in Women With Unexplained Infertility
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Rate of study enrollment
研究概览
简要总结
The study is designed as a proof of concept pilot study with 3 study arms to evaluate the safety and feasibility of the use of oral probiotics and/or antibiotics in women with unexplained infertility/endometriosis. Our secondary outcomes will assess In Vitro Fertilization outcomes, and changes in the uterine microbiota (bacteria), intestinal barrier integrity, and urinary metabolites in response to study interventions.
详细描述
Previous research has demonstrated that the uterine microbiota can impact fertility and embryo implantation. This information leads to the hypothesis that prophylactic antibiotic and/or probiotic treatment may improve reproductive outcomes in women with unexplained infertility/endometriosis who are seeking In Vitro Fertilization (IVF). No therapeutic protocols to improve these outcomes currently exist. However, there are safe and easily accessible medications and supplements that may be able to optimally modify the uterine microbiota. Herein we are proposing a proof of concept pilot study of the feasibility, safety and tolerability of administering oral probiotics, or oral probiotics in combination with antibiotics, to women seeking IVF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Female aged 18-40 at the time of egg retrieval
- •Generally in good health (at physician's discretion)
- •Diagnosed with Unexplained Infertility
- •Diagnosed with or suspected of having endometriosis (at ONE Fertility physician's discretion)
- •Normal uterine cavity as assessed by prior sonohysterogram
- •Planning to undergo Frozen Embryo Transfer with ≥1 frozen blastocyst ≥3BB (grade Gardner) to transfer
- •Able to understand, comply and consent to protocol requirements and instructions
- •Able to attend scheduled study visits and complete required investigations
排除标准
- •Any known endometrial pathologies other than endometriosis
- •Polycystic ovary syndrome
- •Ovulatory dysfunction
- •Male factor infertility (Total Motile Sperm Count <5M/mL)
- •Poorly controlled auto-immune disease and/or diabetes (at physician's discretion)
- •Is immune-compromised
- •Cockayne syndrome
- •Allergy to Metronidazole
- •Allergy to rice (bran and hull), pomegranate, Acacia gum, hypromellose, fermented gellan gum, chlorophyllin, or sunflower oil
- •Known intolerance of Lactobacillus and/or Bifidobacterium-containing probiotics
- •Antibiotic use in the past month
- •Use of any of the following:
- •Oral probiotics
- •Anticoagulant therapies (Warfarin type)
- •Drugs containing alcohol
- •Cyclosporin
- •5-Fluoruracil
- •Phenytoin or Phenobarbital
- •Proton pump inhibitors
- •Histamine H2-receptor antagonists
- •Currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
研究组 & 干预措施
Probiotic + Antibiotic Placebo
干预措施: SH-DS01 + Antibiotic Placebo (Other)
Probiotic + Antibiotic
干预措施: SH-DS01 + Metronidazole (Drug)
Probiotic Placebo + Antibiotic Placebo
干预措施: Probiotic Placebo + Antibiotic Placebo (Other)
结局指标
主要结局
Rate of study enrollment
时间窗: Screening
Evaluated by number of eligible participants consenting to enrollment in the study.
Incidence of intervention-emergent adverse events
时间窗: Immediately after the intervention
Evaluated as the percentage of adverse events occurring in each intervention group.
Rate of retention of study participants
时间窗: Immediately after the intervention
Evaluated by number of study participants who complete, drop out or withdraw from the study.
Proportion of participants adhering to study protocol
时间窗: Immediately after the intervention
Evaluated as the percentage of study participants reporting daily administration of study interventions throughout the intervention period.
次要结局
- Change in intestinal permeability(Baseline, immediately after interventions)
- Difference in implantation rate(Endpoint of interventions to 4 weeks gestation (if applicable))
- Change in uterine microbiota composition(Baseline, immediately after interventions)
- Change in serum LPS(Baseline, immediately after interventions)
- Difference in ongoing pregnancy rate(Endpoint of interventions to 12 weeks gestation (if applicable))
- Change in peripheral cytokines(Baseline, immediately after interventions)
- Change in urinary metabolites(Baseline, immediately after interventions)
- Difference in clinical pregnancy rate(Endpoint of interventions to 6 weeks gestation (if applicable))
研究者
Jocelyn Wessels
Postdoctoral Fellow
McMaster University