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Fertility-Sparing Surgery Combined with Tiaozhou Granules to Promote Ovarian Function Recovery in Ovarian Malignancy: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.

Clinical Study on Integrated Traditional Chinese and Western Medicine for Fertility-Sparing Treatment of Ovarian Malignancies

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000592
Enrollment
Unknown
Registered
2026-03-18
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Borderline Ovarian Tumor, Ovarian Germ Cell Tumor

Interventions

Integrated Chinese-Western Medicine Group:Western standard treatment in conjunction with Tiaozhou Yang-Tonifying / Tiaozhou Yin-Nourishing Granules.
Western Medicine (Control) Group:Western standard treatment plus placebo

Sponsors

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-40 years; 2. Meeting the fertility preservation criteria outlined in the Chinese Expert Consensus on Fertility-Sparing Treatment for Ovarian Malignancies and the Chinese Expert Consensus on Diagnosis and Treatment of Borderline Ovarian Tumors; 3. ECOG Performance Status score: 0-2; 4. Pathologically confirmed diagnosis of primary ovarian germ cell tumor or borderline ovarian tumor; 5. Having undergone fertility-sparing surgery; 6. Young patient with a strong desire for fertility, no other contraindications to fertility, and no contraindications to pregnancy; 7. Ability to comply with strict follow-up requirements; 8. Patient is fully informed of the treatment risks, provides informed consent, and voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. No pathological diagnosis; 2. Severe primary diseases of the heart, liver, lungs, kidneys, or hematopoietic system, or other serious conditions that affect survival; 3. Inability to provide fully informed consent; 4. Other conditions deemed unsuitable for inclusion by the investigator, such as high risk of loss to follow-up due to job relocation, etc.; 5. Patients currently participating in other clinical studies; 6. Patients requiring chemotherapy or other molecular targeted therapy before or after surgery.

Design outcomes

Primary

MeasureTime frame
ovarian reserve improvement rate;Patient Quality of Life Score;

Secondary

MeasureTime frame
Tumor Recurrence Rate;Pregnancy Rate;Live Birth Rate;Preterm Birth/Abortion Rate;

Countries

china

Contacts

Public ContactWenjun cheng

the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province People's Hospital)

chengwenjun@jsph.org.cn13912996970

Outcome results

None listed

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