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A Clinical Study on You's Zhuluan Formula in the Treatment of Infertile Patients with Diminished Ovarian Reserve"

A Clinical Study on You's Zhuluan Formula in the Treatment of Infertile Patients with Diminished Ovarian Reserve"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000871
Enrollment
Unknown
Registered
2025-04-28
Start date
2025-05-02
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Diminished Ovarian Reserve

Interventions

Treatment Group:1) You's Fertility-Enhancing Formula: Taken from day 3 to day 16 of the menstrual cycle, 14 doses per cycle, continuously for 3 cycles. 2) Ovulation Monitoring: Perform transvaginal ul
Control Group:Hormonal Therapy: Starting on day 5 of the menstrual cycle, letrozole 5 mg is taken orally once daily in the evening for 5 consecutive days. From day 16, dydrogesterone 10 mg is added, t

Sponsors

The First Affiliated Hospital of Hunan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Female patients aged 18-40 years (inclusive) with fertility needs; (2) Unprotected sexual intercourse for at least 12 months without pregnancy and a clear diagnosis of infertility; (3) Patients diagnosed with ovarian reserve dysfunction (DOR) and ovulatory dysfunction according to Western medicine criteria (based on the 2022 "Expert Consensus on the Clinical Diagnosis and Treatment of Ovarian Reserve Dysfunction": AMH < 1.1 ng/mL; antral follicle count (AFC) < 5-7 on both ovaries; and a basal FSH level = 10 IU/L during two consecutive menstrual cycles); (4) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe organic diseases such as endometriosis adenomyosis or uterine fibroids; (2) Severe liver or kidney dysfunction a history of malignant tumors or major systemic diseases following radiotherapy or chemotherapy; (3) Age below 18 or above 40 years; (4) Infertility caused by other factors such as tubal factors autoimmune factors anatomical factors of the reproductive organs or male factors; (5) Patients currently participating in other clinical trials; (6) Patients with allergies (defined as allergy to two or more drugs or foods or known allergies to any components of the investigational drug used in this trial); (7) Patients receiving long-term exogenous hormone therapy; (8) Patients who do not meet the inclusion criteria have not followed the prescribed medication regimen cannot assess efficacy or have incomplete data that may affect the safety assessment.

Design outcomes

Primary

MeasureTime frame
Pregnancy rate;ovulation rate;

Secondary

MeasureTime frame
AMH;Antral follicle count (AFC);Traditional Chinese Medicine Syndrome Score;sex hormone levels;

Countries

China

Contacts

Public ContactLiu Wene

The First Affiliated Hospital of Hunan University of Chinese Medicine

liuwene@163.com+86 135 7487 2658

Outcome results

None listed

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