An Interventional Study Evaluating Telomere and Biological Aging Hallmarks Profiling to Guide an Integrative Traditional Chinese and Conventional Medicine Approach in Women With Post-Treatment Unexplained Infertility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Clinical Pregnancy Rate per Conception Attempt
研究概览
简要总结
The goal of this clinical trial is to determine whether telomere profiling and other biological aging hallmarks can help identify underlying mechanisms of persistent infertility in women with post-treatment unexplained infertility. The study also evaluates whether a personalized integrative treatment guided by these biomarkers can improve reproductive outcomes.
The study includes women aged 25 to 42 years who continue to experience infertility despite appropriate management of identifiable reproductive conditions and repeated attempts with assisted reproductive technologies (ART), such as intrauterine insemination (IUI) or in vitro fertilization (IVF).
The main questions this study aims to answer are:
- Can telomere and biological aging hallmarks profiling identify a biological aging phenotype associated with infertility?
- Can an integrative treatment guided by these profiles improve clinical pregnancy outcomes?
Participants will:
- Undergo a baseline reproductive evaluation and blood-based assessment of telomeres and aging hallmarks.
- Receive an integrative approach combining Traditional Chinese Medicine (TCM), targeted nutritional support, and standard fertility care.
- Proceed with natural conception attempts or standard assisted reproductive technologies following the preconception phase.
- Participants will be followed to assess pregnancy outcomes and changes in biological aging hallmarks.
详细描述
- Scientific Background and Clinical Need
Infertility affects approximately one in six couples worldwide. In up to 40 percent of cases, no clear etiology can be identified even after comprehensive clinical and laboratory evaluation, a condition traditionally defined as idiopathic infertility. In parallel, a growing number of women experience persistent reproductive failure despite adequate management of identifiable conditions such as endometriosis, polycystic ovary syndrome, or hormonal imbalance. This category, referred to as post-treatment unexplained or functionally idiopathic infertility, includes patients whose anatomical and endocrine parameters appear normalized, yet who continue to experience repeated ART failures, whether through intrauterine insemination or in vitro fertilization.
Both idiopathic and post-treatment unexplained infertility reveal a fundamental limitation of current diagnostic frameworks. Conventional assessments may normalize structural or hormonal parameters while overlooking deeper molecular dysfunctions that impair reproductive capacity.
Emerging evidence suggests that many of these cases correspond to an unrecognized form of reproductive aging, in which cellular and molecular decline within reproductive tissues occurs earlier than chronological aging would predict. In other words, the reproductive system becomes biologically older than the patient's calendar age.
Conventional diagnostic tools primarily assess quantitative and structural parameters such as hormonal levels, oocyte count, uterine morphology, or tubal patency. However, these metrics fail to capture the qualitative dimensions of cellular health, particularly those associated with the hallmarks of aging such as telomere erosion, mitochondrial dysfunction, and cellular senescence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. No parties are masked to the intervention. Participants, investigators, and assessors are aware of the assigned treatment.
入排标准
- 年龄范围
- 25 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biological female participants aged 25 to 42 years.
- •Diagnosis of infertility defined as failure to conceive after at least 12 months of unprotected intercourse and/or repeated failure of assisted reproductive technologies (ART), including intrauterine insemination (IUI) and/or in vitro fertilization (IVF).
- •History of post-treatment unexplained or functionally idiopathic infertility, defined as persistent infertility despite adequate correction or management of identifiable reproductive conditions (e.g., endometriosis, polycystic ovary syndrome, hormonal imbalance, uterine factors).
- •Eligibility for natural conception attempts and/or assisted reproductive technologies according to routine clinical practice.
- •Willingness to undergo biological aging biomarker profiling, including leukocyte telomere analysis.
- •Ability and willingness to comply with study procedures, including the preconception integrative intervention and follow-up assessments.
- •Provision of written informed consent prior to participation.
排除标准
- •Current pregnancy or breastfeeding at the time of enrollment.
- •Known chromosomal abnormalities or genetic conditions directly impairing fertility (e.g., Turner syndrome).
- •Untreated severe male factor infertility precluding conception by natural or standard ART methods.
- •Active malignancy or history of cancer requiring systemic treatment within the past 5 years.
- •Severe systemic disease or medical condition contraindicating pregnancy or participation in ART (as determined by the treating physician).
- •Use of investigational drugs or participation in another interventional clinical trial that could interfere with the study outcomes.
- •Known hypersensitivity or contraindication to components of the integrative intervention, as determined by clinical assessment.
- •Any condition which, in the opinion of the investigator, would interfere with safe participation or interpretation of study results.
研究组 & 干预措施
Biological Aging-Informed Integrative Fertility Intervention
Participants assigned to this arm undergo a baseline reproductive evaluation and molecular profiling related to biological aging, including leukocyte telomere analysis. Women presenting biological aging-related molecular signatures complete a personalized preconception integrative intervention lasting 4 to 12 weeks prior to natural conception attempts or IUI / IVF.
The intervention combines individualized botanical formulations derived from TCM and targeted nutraceutical supplementation, administered alongside standard fertility care. These interventions are intended to support telomere-related cellular integrity, mitochondrial function, regulation of cellular senescence associated pathways, oxidative balance, and overall tissue homeostasis.
Following the preconception phase, participants proceed with natural conception attempts or ART while continuing the integrative support. Clinical pregnancy outcomes & changes in molecular and reproductive parameters are prospectively assessed.
干预措施: 2. Integrative Botanical and Nutraceutical Intervention (Other)
Biological Aging-Informed Integrative Fertility Intervention
Participants assigned to this arm undergo a baseline reproductive evaluation and molecular profiling related to biological aging, including leukocyte telomere analysis. Women presenting biological aging-related molecular signatures complete a personalized preconception integrative intervention lasting 4 to 12 weeks prior to natural conception attempts or IUI / IVF.
The intervention combines individualized botanical formulations derived from TCM and targeted nutraceutical supplementation, administered alongside standard fertility care. These interventions are intended to support telomere-related cellular integrity, mitochondrial function, regulation of cellular senescence associated pathways, oxidative balance, and overall tissue homeostasis.
Following the preconception phase, participants proceed with natural conception attempts or ART while continuing the integrative support. Clinical pregnancy outcomes & changes in molecular and reproductive parameters are prospectively assessed.
干预措施: 3. Natural Conception or Assisted Reproductive Technologies (Procedure)
Biological Aging-Informed Integrative Fertility Intervention
Participants assigned to this arm undergo a baseline reproductive evaluation and molecular profiling related to biological aging, including leukocyte telomere analysis. Women presenting biological aging-related molecular signatures complete a personalized preconception integrative intervention lasting 4 to 12 weeks prior to natural conception attempts or IUI / IVF.
The intervention combines individualized botanical formulations derived from TCM and targeted nutraceutical supplementation, administered alongside standard fertility care. These interventions are intended to support telomere-related cellular integrity, mitochondrial function, regulation of cellular senescence associated pathways, oxidative balance, and overall tissue homeostasis.
Following the preconception phase, participants proceed with natural conception attempts or ART while continuing the integrative support. Clinical pregnancy outcomes & changes in molecular and reproductive parameters are prospectively assessed.
干预措施: 1. Aging Hallmarks Biomarker Profiling (Telomere-Based) (Other)
结局指标
主要结局
Clinical Pregnancy Rate per Conception Attempt
时间窗: From initiation of the conception attempt until confirmation of clinical pregnancy, assessed up to 12 months.
Clinical pregnancy defined as the presence of an intrauterine gestational sac confirmed by transvaginal ultrasound following a natural conception attempt or assisted reproductive technology (IUI or IVF) cycle.
次要结局
- Change in Percentage of Critically Short Telomeres (<5 kb)(Assessed from baseline to 3 months after initiation of the integrative intervention; participants without sufficient biological response at 3 months may undergo a second assessment at 6 months.)
- Safety and Tolerability of the Integrative Intervention(From initiation of the integrative intervention through study completion (up to 12 months).)
- Change in Telomere Length Distribution Profile(Assessed from baseline to 3 months after initiation of the integrative intervention; participants without sufficient biological response at 3 months may undergo a second assessment at 6 months.)
- Change in Mean Leukocyte Telomere Length(From baseline to 3 months after initiation of the integrative intervention, with an additional assessment at 6 months if the biological response at 3 months is insufficient.)
- Change in Serum Anti-Müllerian Hormone (AMH) Level(From baseline to 3 months after initiation of the integrative intervention, with an additional assessment at 6 months if the biological response at 3 months is insufficient.)
- Change in Serum Follicle-Stimulating Hormone (FSH) Level(From baseline to 3 months after initiation of the integrative intervention, with an additional assessment at 6 months if the biological response at 3 months is insufficient.)
- Change in Antral Follicle Count (AFC)(Assessed from baseline to 3 months after initiation of the integrative intervention; participants without sufficient biological response at 3 months may undergo a second assessment at 6 months.)