Clinical Trial of Anovulatory Infertility

NCT ID: NCT06601452

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2028-12-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chinese medicine treatment group（PCOS）

Beginning on day 5 of the menstrual cycle, the treatment group was treated with a combination of Zi Yin and Yang Formula sequential treatment based on the control group, and Zi Yin and Yang Formula sequential treatment (Tuning Zhou Zi Yin Granules + Tuning Zhou and Yang Granules) was used in the 3 menstrual cycles prior to the IVF advancement week. Starting on the 5th day of the menstrual cycle, take the Tuning Zhou Zi Yin Granules (in-hospital preparation) orally. 2 packets each time, 3 times a day, 14 days of treatment; regulating Zhou Zhi Yin Granules (hospital preparation development), oral. Take 2 sachets each time, 3 times a day for 14 days.

Group Type: EXPERIMENTAL

a compound prescription of Chinese medicine

Intervention Type: DRUG

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.

Chinese medicine treatment group（DOR）

Beginning on day 5 of the menstrual cycle, the treatment group was treated with a combination of Zi Yin and Yang Formula sequential treatment based on the control group, and Zi Yin and Yang Formula sequential treatment (Tuning Zhou Zi Yin Granules + Tuning Zhou and Yang Granules) was used in the 3 menstrual cycles prior to the IVF advancement week. Starting on the 5th day of the menstrual cycle, take the Tuning Zhou Zi Yin Granules (in-hospital preparation) orally. 2 packets each time, 3 times a day, 14 days of treatment; regulating Zhou Zhi Yin Granules (hospital preparation development), oral. Take 2 sachets each time, 3 times a day for 14 days.

Group Type: EXPERIMENTAL

a compound prescription of Chinese medicine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Affiliated Hospital of Nanjing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2024NL-111-02

Identifier Type: -

Identifier Source: org_study_id