💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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 Criteria:
* 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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