Clinical Trial

Clinical Trial of Anovulatory Infertility

Enrolling by Invitation Early Phase 1
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Summary
This project aims to study the expression of clock genes and related proteins in follicular fluid and granulosa cells, depicting the periodic, amplitude, and phase changes of biological clock genes and related proteins in women of different ages during the reproductive period and in patients with ovulatory disorders. The study compares the periodicity, amplitude, and phase changes of Clock/Bmal1-TTFLs-klotho related proteins and genes in PCOS, DOR patients, and age-matched women with normal ovarian function, aiming to identify the key segments of ovarian clock gene period rhythm disorder under different disease states, and screen the key time points of clock gene oscillation abnormality. Omics analysis of the differences between groups, analysis of the relationship between gene transcription translation, protein expression, metabolites, and the expression of clock genes, and deduction of the dynamic changes and interaction relationships of the biological processes within the ovaries in regulating ovulatory disorders using the method of reinforcing the kidney and regulating the menstrual cycle. This aims to clarify that maintaining the ovarian biological clock period rhythm is an important biological basis for "the kidney dominating reproduction". The regulation mechanism of the treatment of ovulatory disorders using the method of reinforcing the kidney and regulating the menstrual cycle is explained from the perspective of the ovarian biological clock period rhythm.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-13.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-02-10
Trial Details
NCT Number NCT06601452
Lead Sponsor Affiliated Hospital of Nanjing University of Chinese Medicine
Conditions Polycystic Ovary Syndrome, Diminished Ovarian Reserve, Ovulation Disorder
Enrollment 650 participants
Start Date 2024-09-30
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-11