NCT06601452

Clinical Trial of Anovulatory Infertility

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

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Affiliated Hospital of Nanjing University of Chinese Medicine · Academic / Other
• Sex: Female
• Age: 20 Years – 41 Years
• Healthy volunteers: Accepted

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.

Conditions

• Polycystic Ovary Syndrome
• Diminished Ovarian Reserve
• Ovulation Disorder

Interventions

Type	Name	Description
DRUG	a compound prescription of Chinese medicine	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.

Timeline

• Start date: 2024-09-30
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2024-09-19
• Last updated: 2025-02-11

Locations

1 site across 1 country: China