Biological Aging Hallmarks-Guided Integrative TCM and Conventional Medicine in Post-Treatment Unexplained Female Infertility
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
BEYOND GENOMiX SA, AG, Ltd
15 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria8
- 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.
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Interventions
Participants undergo baseline molecular profiling of biological aging biomarkers derived from the hallmarks of aging framework, with a primary focus on telomere-related parameters measured in peripheral blood leukocytes. Telomere analysis includes assessment of mean telomere length, the percentage of critically short ("super-short") telomeres, and telomere-length distribution profiles. Together, these biomarkers provide a measure of biological age and define molecular signatures of cellular aging relevant to ovarian and reproductive tissue function, including processes associated with telomere attrition, cellular senescence, and downstream aging hallmarks. Molecular parameters are assessed at baseline and, where applicable, longitudinally according to the study protocol for stratification and monitoring purposes.
Participants receive a personalized integrative intervention consisting of botanical formulations derived from Traditional Chinese Medicine (TCM) and targeted nutraceutical supplementation during a preconception period of 4 to 12 weeks. The intervention is administered alongside standard fertility care and is informed by biological aging-related molecular signatures. The integrative support is intended to address biological processes associated with aging hallmarks, including telomere-related cellular integrity, mitochondrial function, cellular senescence-associated pathways, oxidative balance, and tissue homeostasis.
Following completion of the preconception phase and confirmation of stabilization of biological aging-related molecular profiles associated with the hallmarks of aging, participants proceed to conception attempts either through natural cycles or through assisted reproductive technologies, including intrauterine insemination (IUI) or in vitro fertilization (IVF), according to clinical indication. Assisted reproductive procedures are conducted in accordance with standard clinical practice and local guidelines. The choice of conception method is determined by routine clinical criteria and participant preference. No experimental modifications to standard ART protocols are introduced as part of this intervention.
Locations(1)
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NCT07404969