Fecal Microbiota Transplantation for the Treatment of Polyendocrine Metabolic Ovarian Syndrome in Obese Women:A Phase Ⅰ/ⅡSingle-Arm Pilot Study and Planned Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
This prospective, two-stage clinical trial aims to evaluate the safety, preliminary efficacy, and reproductive outcomes of oral Fecal Microbiota Transplantation (FMT) freeze-dried capsules in overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) undergoing Frozen-Thawed Embryo Transfer (FET).The study is implemented in two sequential phases:
Phase Ⅰ (Pilot Exploration): A prospective, open-label, single-arm exploratory study in an initial evaluable cohort (n=11) to evaluate preliminary safety, dynamic gut microbiota colonization, endocrine/metabolic parameters, and pregnancy outcomes following FET.
Phase Ⅱ (Confirmatory RCT): A planned multicenter, prospective, randomized controlled trial (RCT) designed to validate the clinical efficacy and underlying mechanisms of oral FMT capsules compared with control interventions, based on findings established in Phase Ⅰ.
详细描述
Background:Polyendocrine Metabolic Ovarian Syndrome (PMOS), formerly recognized as Polycystic Ovary Syndrome (PCOS), is a systemic disorder characterized by hyperandrogenism, insulin resistance, chronic low-grade inflammation, and gut microbiota dysbiosis. These abnormalities frequently impair endometrial receptivity, oocyte quality, and clinical pregnancy outcomes in assisted reproductive technology (ART) cycles. Fecal Microbiota Transplantation (FMT) offers a targeted approach to restore gut microecology and alleviate metabolic-endocrine dysfunction.
Study Design:This study adopts a prospective, two-stage sequential implementation framework.
Phase 1 (Single-Arm Exploratory Pilot Stage):
Objective: To establish preliminary safety, tolerability, gut microbiota remodeling, and reproductive feasibility of oral FMT in PMOS patients undergoing FET.
Cohort: An initial exploratory cohort of 11 evaluable overweight or obese patients with PMOS (BMI≥24.0kg/m2) scheduled for Frozen-Thawed Embryo Transfer (FET).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Females aged 20 to 40 years old.
- •2. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS).
- •3. Body Mass Index (BMI): >24 kg/m²(covering overweight and obese patients according to Asian criteria, addressing the actual recruited cohort ranging from 24 kg/m² upwards).
- •4. Scheduled to undergo Frozen-Thawed Embryo Transfer (FET) at the Reproductive Medicine Center.
- •5. Voluntary participation with signed Informed Consent Form (ICF).
排除标准
- •Age < 20 or > 40 years.
- •Pregnancy or lactation.
- •Other endocrine disorders (e.g., Cushing's syndrome, thyroid dysfunction); severe organ dysfunction or impaired intestinal mucosal barrier; use of antibiotics, probiotics, or prebiotics within 1 month.
- •Use of ovulation-modifying or anti-androgen drugs within 3 months; severe psychiatric disorders.
- •Concurrent participation in other clinical trials.
研究组 & 干预措施
Oral FMT Capsules Group
Participants in this experimental arm are overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) scheduled for Frozen-Thawed Embryo Transfer (FET). They will receive standardized oral fecal microbiota transplantation (FMT) capsules without antibiotic pretreatment. Standardized lifestyle and dietary guidance will be provided throughout the study.
干预措施: oral Fecal Microbiota Transplantation (Biological)
Placebo Capsules Group
Participants in this comparing arm are overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) scheduled for Frozen-Thawed Embryo Transfer (FET). They will receive visually and olfactory-matched placebo capsules without antibiotic pretreatment. Standardized lifestyle and dietary guidance will be provided throughout the study.
干预措施: Placebo (Other)
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: Assessed up to 8 weeks following the Frozen-Thawed Embryo Transfer (FET)(approximately within 6 months following the completion of the FMT intervention).
The percentage of participants who achieve a confirmed clinical pregnancy, defined as the presence of at least one intrauterine gestational sac with a viable fetal heartbeat confirmed by transvaginal ultrasound.
Biochemical Pregnancy Rate
时间窗: Assessed at 14 days following the Frozen-Thawed Embryo Transfer (FET)
The percentage of participants who achieve a biochemical pregnancy, confirmed by a serum beta-hCG level \> 10 mIU/mL.
Incidence of Adverse Events (AEs)
时间窗: Assessed from the first dose of FMT through the 12-week post-treatment follow-up
The number of participants experiencing any treatment-related adverse events or serious adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0),including diarrhea,bloating,abdominal pain,constipation,etc.
次要结局
- Change in Body Mass Index (BMI)(Baseline and 4 weeks post-FMT.)
- Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.)
- Change in Serum Total Testosterone (T) Level(Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.)
- Change in Serum Luteinizing Hormone (LH) Level(Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.)
- Change in Serum Interleukin-6 (IL-6) Level(Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.)
- Change in Gut Microbiota Alpha Diversity (Shannon Index)(Baseline and 4 weeks post-FMT.)
- Live Birth Rate (LBR)(Assesssed up to 42 weeks following the Frozen-Thawed Embryo Transfer (FET))
研究者
Ningxia Sun
Principal Investigator
Shanghai Changzheng Hospital