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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 42
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Switzerland
BEYOND GENOMiX Research and Coordination Center
RECRUITING
Neuchâtel
Contact Information
Primary
MYRIAM MERARCHI
myriam.merarchi@beyondgenomix.com
+41783061737
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 15
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: BEYOND GENOMiX SA, AG, Ltd
Collaborators: Praxis für Akupunktur und Chinesische Arzneimittel, Fertisuisse Ltd, SA, AG

This content was sourced from clinicaltrials.gov