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Clinical Efficacy Observation of Integrated Traditional Chinese and Western Medicine Medications for Restoring Fertility in Patients with Premature Ovarian Insufficiency

Clinical Efficacy Observation of Integrated Traditional Chinese and Western Medicine Medications for Restoring Fertility in Patients with Premature Ovarian Insufficiency

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108301
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-03-16
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diminished ovarian reserve (DOR)

Interventions

Control group:Ursodeoxycholic Acid Capsules0.5g/day (0.25g/time, 2times/day) and Dimethyl fumarate 480mg/day (240mg/time, 2times/day)
Experimental group:Pig bile powder 0.6g/day (0.3g/time, 2times/day) and Dimethyl fumarate 480mg/day (240mg/time, 2times/day)

Sponsors

Hebei Maternity Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Previously undergone in vitro fertilization (IVF) treatment at our hospital. 2.Women aged 20 - 40 years who meet the diagnostic criteria for diminished ovarian reserve (DOR) or premature ovarian insufficiency (POI) (Spontaneous menstruation with AMH<=0.5, bilateral antral follicle count<=6); 3.Normal chromosomal karyotype. 4.No contraindications to the medications used in this study. 5.Normal hepatic and renal function. 6.Body mass index (BMI) < 30 kg/m^2.

Exclusion criteria

Exclusion criteria: 1.Infertile women whose infertility is not attributable to diminished ovarian function. 2.Women with severe cardiovascular, pulmonary, hepatic, or renal diseases; 3.Individuals with untreated sexually transmitted diseases (STDs) such as acquired immunodeficiency syndrome (AIDS), syphilis, Neisseria gonorrhoeae, or Chlamydia infections; 4.Women with a confirmed or suspected malignant tumor. 5.Women presenting with uterine organic pathologies such as uterine malformations, adenomyosis, uterine fibroids, endometrial hyperplasia; 6.Individuals with abnormal hepatic and renal function test results. 7.Women with chromosomal aberrations. 8.Patients currently receiving pharmacotherapy for other systemic diseases. 9.Participants currently enrolled in other clinical trials. 10.those with chronic conditions including diabetes mellitus, hypertension, hematological disorders, thrombotic diseases, autoimmune diseases, etc.; 11.those with comorbidities that pose a significant threat to patient safety or may impede the patient's ability to complete this study. 12.those with unresolved reproductive tract infectious diseases; 13.those with unremediated alcoholism, drug addiction, or substance abuse problems. 14.those with reproductive organ pathologies including hydrosalpinx or ovarian cysts.

Design outcomes

Secondary

MeasureTime frame
Liver and kidney function;

Primary

MeasureTime frame
Ovarian indicators: ovarian volume, peak systolic velocity (PSV) and pulsatility index (PI) of ovarian artery blood flow, antral follicle count (AFC), and follicle size;Sex hormone six items - E2, P, FSH, LH, T, PRL;Anti-Müllerian hormone - AMH;

Countries

China

Contacts

Public ContactKai Deng

Hebei Maternity Hospital

dkeanig@163.com+86 311 85333286

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026