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The Protection Role of Metformin in Female Reproductive System Development and Fertility Preservation for children with malignant tumors with Chemotherapy: A Double-Blind, Randomized, Placebo-Controlled Study

The Protection Role of Metformin in Female Reproductive System Development and Fertility Preservation for children with malignant tumors with Chemotherapy: A Double-Blind, Randomized, Placebo-Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023489
Enrollment
Unknown
Registered
2019-05-31
Start date
2019-11-30
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

Childhood malignancy (leukemia, lymphoma, rhabdomyosarcoma, etc.)

Interventions

Sponsors

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

Eligibility

Sex/Gender
Female
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1) Women aged 10-18; 2) identified as a child malignant tumor (rapid lymph, acute marrow, solid tumor, rhabdomyosarcoma, etc.); 3) receiving chemotherapy; 4) Development is in accordance with age; 5) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with precocious puberty and gonadal dysplasia; 2) Patients with severe comorbidities who cannot tolerate chemotherapy; 3) Those who have a history of diabetes who are taking any hypoglycemic agents; 4) Those who have received chemotherapy and pelvic area radiotherapy before; 5) known to be allergic to metformin hydrochloride and its analogues; 6) Patients who are participating in or have participated in other clinical trials for the past 3 months; 7) Oral contraceptives or hormonal drugs during the trial; 8) Other patients identified by the investigator as unfit for the study;

Design outcomes

Primary

MeasureTime frame
Anti-Mullerian hormone;

Secondary

MeasureTime frame
The quality of second sexual;sexual hormon+InhibinB;Bone age assessment;Safety assessment;menarche;

Countries

China

Contacts

Public ContactShixuan Wang

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