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The Clinical Study of Metformin in Ovarian Reserve and Function Protection for Cervical Cancer Survivors Treated with Chemotherapy

The Protection Role of Metformin in Ovarian Reserve and Function for Cervical Cancer Survivors Treated with Chemotherapy: A Double-Blind, Randomized, Placebo-Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023488
Enrollment
Unknown
Registered
2019-05-31
Start date
2019-10-22
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

Cervical cancer

Interventions

Sponsors

Tongji hospital,Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Age: 18-45 years old; 2) Preoperative pathological diagnosis of cervical squamous cell carcinoma or cervical adenosquamous carcinoma or cervical adenocarcinoma 3) Clinical diagnosis is IB2 (with fertility requirements), IB3 and IIA2; 4) retain one or both sides or part of the ovaries; 5) normal ovarian function before chemotherapy (regular menstruation 2 months before chemotherapy); 6) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those who have received chemotherapy and pelvic area radiotherapy before; 2) Combine endocrine diseases (such as PCOS, hyperprolactinemia, hyperandremia, adrenal dysfunction, etc.) that affect ovarian function; 3) Combine cardiovascular, liver, kidney, infectious diseases, hematopoietic system and other serious diseases, with a history of lactic acidosis or high risk factors; 4) distant metastasis of cervical cancer; 5) pregnant or lactating women; 6) A history of diabetes is currently taking any hypoglycemic agent; 7) known to be allergic to metformin hydrochloride and its analogues; 8) Patients who are participating in or have participated in other clinical trials in the past 3 months; 9) oral contraceptives or hormonal drugs during the trial; 10) Other patients identified by the investigator as unfit for the study;

Design outcomes

Primary

MeasureTime frame
Anti-Mullerian hormone;

Secondary

MeasureTime frame
Sex hormone+InhibinB;5-year pregnancy outcome;Tumor prognosis;Patient quality of life;Safety assessment;

Countries

China

Contacts

Public ContactShixuan Wang

Tongji hospital,Tongji Medical College, Huazhong University of Science and Technology

sxwang@tjh.tjmu.edu.cn+86 027 83663180

Outcome results

None listed

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