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NCT06601452
Clinical Trial of Anovulatory Infertility
EARLY_PHASE1 trial testing a compound prescription of Chinese medicine in Polycystic Ovary Syndrome in 650 participants. Enrolling by invitation.
31 December 2028
Quick facts
| Lead sponsor | Affiliated Hospital of Nanjing University of Chinese Medicine |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 650 |
| Start date | 30 September 2024 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- a compound prescription of Chinese medicine — full drug profile →
Conditions studied
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
- Diminished Ovarian Reserve — all drugs for Diminished Ovarian Reserve →
- Ovulation Disorder — all drugs for Ovulation Disorder →
Sponsor
Affiliated Hospital of Nanjing University of Chinese Medicine
Who can join
Adults 20 to 41, female only, with Polycystic Ovary Syndrome or Diminished Ovarian Reserve. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06601452
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Other Affiliated Hospital of Nanjing University of Chinese Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06601452 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Affiliated Hospital of Nanjing University of Chinese Medicine
- Last refreshed: 11 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06601452.
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