Status:
ENROLLING_BY_INVITATION
Clinical Trial of Anovulatory Infertility
Lead Sponsor:
Affiliated Hospital of Nanjing University of Chinese Medicine
Conditions:
Polycystic Ovary Syndrome
Diminished Ovarian Reserve
Eligibility:
FEMALE
20-41 years
Phase:
EARLY_PHASE1
Brief 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 an...
Eligibility Criteria
Inclusion
- 1\) meet the diagnostic criteria of infertility; 2) aged between 28 and 34 years old; 3) meet the diagnostic criteria of PCOS or DOR and the Chinese medicine diagnosis is kidney deficiency, or the ovarian function is normal in the case of IVF fertilization due to the male factor; 4) assisted in fertilization with IVF-ET antagonist or microstimulation; 5) the patients can tolerate the relevant treatment of the present study, and the compliance is good; 6) they have not used any medication before the treatment and have signed the informed consent. 7) Patients who have not used any medication before the treatment and have signed the informed consent for enrollment.
Exclusion
- 1\) Age \> 35 years old; 2) Body mass index (BMI) ≥ 25kg/m2; 3) Abnormal karyotype of either spouse; 4) Uterine infertility, such as endometrial polyps, uterine adhesions, submucosal fibroids, adenomyosis, congenital uterine anomalies, etc.; 5) Endometriosis; 6) Repeated abortion; 7) Untreated hydrosalpinx; 8) Those who had used endocrine-affecting drugs in the last three months; 9) Combination of other contraindications to assisted reproduction techniques for conception such as psychiatric disorders, severely impaired liver or kidney function, thrombotic disorders, and malignant tumors.10) Those who were unable to give full informed consent due to intellectual or behavioral disabilities.11) Suspected or confirmed history of alcohol or drug abuse.12) According to the investigator's judgment (12) Other medical conditions that, in the judgment of the investigator, reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment that may result in loss of visits.13) Allergy, such as a history of allergy to two or more medications or foods, or a known allergy to the components of the medication.14) Patients participating in a clinical trial of another medication.
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT06601452
Start Date
September 30 2024
End Date
December 31 2028
Last Update
February 11 2025
Active Locations (1)
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1
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China, 210000