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Prospective clinical study of oocyte cryopreservation and/or ovarian tissue cryopreservation in patients with early-stage breast cancer

Prospective clinical study of oocyte cryopreservation and/or ovarian tissue cryopreservation in patients with early-stage breast cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048357
Enrollment
Unknown
Registered
2021-07-06
Start date
2021-05-05
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

early-stage breast cancer

Interventions

oocyte cryopreservation:oocyte cryopreservation
ovary tissue cryopreservation:ovary tissue cryopreservation

Sponsors

OBGYN Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
10 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Inclusion criteria for cryopreservation of oocytes: (1) a strong urge to preserve oocytes (2) low-to-moderate risk breast cancer, with the expectation of a long-term prognosis; (3) aged <=40 years; (4) a high probability of impairment of ovarian function due to subsequent treatment, and such treatment has not been performed yet; (5) tolerability to ovulation induction and vaginal oocytes extraction; (6) volunteers to participate in this study, Signed informed consent, good compliance, with follow-up. 2.Inclusion criteria for ovarian tissue cryopreservation: (1) a strong desire to preserve ovarian endocrine function; (2) low-to-moderate risk breast cancer, with the expectation of long-term survival; (3) aged <=40 years; (4) a high probability of ovarian function impairment due to subsequent treatment, and such treatment has not been performed yet; (5) tolerability to laparoscopic surgery; (6) volunteers to participate in this study, Signed informed consent, good compliance, with follow-up.

Exclusion criteria

Exclusion criteria: The tumor involved the ovary or had a high risk of ovarian metastasis, and the clinical prognosis was poor. High recurrence risk: 1. Positive number of lymph nodes is greater than or equal to 4; 2. 1-3 lymph node positives with HER2 positive or triple negative breast cancer; 3. Patients with infectious diseases (HIV, syphilis, hepatitis, etc.); 4. Patients with surgical or anesthetic contraindication; 5. Patients with mental disorders or clear family history of mental diseases 5) Serious familial or hereditary tumors or disease syndromes (gene mutations BRCA1/2, P53, PTEN, etc. not recommended to freeze ovarian tissue after receiving genetic counseling); 6. Other circumstances that do not comply with laws, regulations or ethics.

Design outcomes

Primary

MeasureTime frame
endocrione;

Countries

China

Contacts

Public ContactXu Congjian

OBGYN Hospital of Fudan University

xucongjian1275@fckyy.org.cn+86 13651796353

Outcome results

None listed

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