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Clinical Study of Zuogui Pill in the Treatment of Infertility due to Diminished Ovarian Reserve (DOR): A Multicenter Randomized Controlled Trial

Clinical Study of Zuogui Pill in the Treatment of Infertility due to Diminished Ovarian Reserve (DOR): A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000151
Enrollment
Unknown
Registered
2026-01-24
Start date
2026-01-30
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Infertility due to diminished ovarian reserve

Interventions

Test group:3-month Zuogui Pill + Elevit
control group:3-month Zuogui Pill Placebo + Elevit

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 42 Years

Inclusion criteria

Inclusion criteria: 1.Conform to the diagnostic criteria of DOR and kidney deficiency syndrome ; the diagnostic criteria of DOR were formulated according to the Bologna Consensus and ' Obstetrics and Gynecology ' ( Ninth Edition ), ' Expert Consensus on Clinical Diagnosis and Treatment of Decreased Ovarian Reserve ' ( 2022 ), ' Guidelines for Diagnosis and Treatment of Decreased Ovarian Reserve with Integrated Traditional Chinese and Western Medicine ' ( Chinese Society of Integrated Traditional Chinese and Western Medicine, Chinese Society of Traditional Chinese Medicine, Chinese Medical Association, 2023 ) : ( 1 ) 10 U / L 20 and = 42 years old, have fertility needs ; 4.Voluntary signing of informed consent

Exclusion criteria

Exclusion criteria: (1) Other clear causes of infertility (e.g., fallopian tube obstruction, endometriosis stage III-IV); (2) Severe gynecological diseases, DOR caused by prior ovarian surgery, radiotherapy/chemotherapy, or chromosomal abnormalities; (3) Severe systemic diseases (e.g., uncontrolled hypertension, diabetes) or malignancies; (4) Use of hormonal medications or TCM treatments within 3 months; (5) Patients with predominant Kidney Yang deficiency; (6) Failure to undergo IVF-ET within 3 months after TCM treatment.

Design outcomes

Primary

MeasureTime frame
Anti-Müllerian Hormone (AMH);Total Oocytes Retrieved Through Assisted Reproductive Technology;

Secondary

MeasureTime frame
Sex Hormone Levels;Antral Follicle Count (AFC);High-Quality Embryo Rate;Clinical Pregnancy Rate;Biochemical Pregnancy Rate;TCM syndrome score;

Countries

China

Contacts

Public ContactLi Dong

Peking University Third Hospital

lidong6512@163.com15611908373

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026