Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210000, China
NCT Number: NCT06601452
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.
Interested in participating?
Request Info20 year–41 year
Female
Interventional
Early Phase 1
Nanjing, Jiangsu, 210000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The enrolled patients were treated with 3 cycles of sequential treatment with Nourishing Yin and Replenishing Yang formula before entering the cycle (Tuning Weekly Nourishing Yin Granules + Tuning Weekly Replenishing Yang Granules), and the egg retrieval cycle used an antagonist regimen to obtain the eggs.
Time frame: Main symptoms and signs: first day of the initial consultation, the third day of the menstrual cycle without entering the treatment cycle, the day of egg collection, and 14 days after the FET are each observed and recorded once.
Serum indicators: Serum was collected on the 3rd and 21st day of the menstrual cycle before entering the treatment cycle, and ELISA was performed to detect changes in the amount of Bmal1, Clock, klotho, Per1, Per2, Per3, Cry1, Cry2, AMH, INHB, and sex hormones (E2, FSH, LH, P, and T) in the serum.
(2) Follicular fluid index: follicular fluid was retained on the day of ovulation, and changes in the concentration of Bmal1, Clock, klotho, AMH, INHB, and sex hormones (E2, FSH, LH, P, and T) in the follicular fluid were detected by ELISA.
(3) Granulosa cell indexes: Ovarian granulosa cells were cultured in vitro for 24 hours on the day of egg collection, and changes in mRNA and protein of the ovarian clock genes Bmal1, Clock, klotho, Per1, Per2, Per3, Cry1 and Cry2 were detected by qPCR and WB at 3-hour intervals.
(4) Histological indicators: follicular fluid and ovarian granulosa cells were retained on the day of egg collection for UPLC-Q-TOF/MS metabolomics, whole genome microarray genom
Affiliated Hospital of Nanjing University of Chinese Medicine
Other
Exploring the Biological Basis of Tonifying the Kidney and Regulating the Menstrual Cycle in the Treatment of Anovulatory Infertility Based on the Circadian Rhythm of the Biological Clock
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