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A Multicenter, Prospective Cohort Study on Ovarian Function Preservation via Ovarian Tissue Cryopreservation and Auto-Transplantation in Female Pediatric Patients with Acute Lymphoblastic Leukemia

A Multicenter, Prospective Cohort Study on Ovarian Function Preservation via Ovarian Tissue Cryopreservation and Auto-Transplantation in Female Pediatric Patients with Acute Lymphoblastic Leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120223
Enrollment
Unknown
Registered
2026-03-11
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

acute lymphoblastic leukemia

Interventions

Experiment Group (Ovarian Tissue Cryopreservation):None
Control Group (Absence of Ovarian Tissue Cryopreservation):None

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as a pediatric patient with ALL, according to the diagnostic criteria referenced from the NCCN Guidelines 2025 V2: >=20% blasts and immature lymphocytes were found in bone marrow aspirate and biopsy specimens. If there is a sufficient number of circulating blasts and immature lymphocytes in peripheral blood (>=1x10?/L) and the clinical situation does not permit bone marrow aspiration and biopsy, peripheral blood can be used as a substitute for bone marrow. 2. Aged 7-13 years, female, premenarchal, with requirements for endocrine function and fertility preservation, and in complete remission after receiving prior non-alkylating agent-based chemotherapy. 3. Laboratory examination: AMH =50%.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded: 1. Patients with contraindications to laparoscopic surgery. 2. Patients with critical illness or poor prognosis. 3. Patients who have received chemotherapy with high-risk ovarian damaging agents (alkylating agents) or radiotherapy. 4. Patients with severe endocrine, metabolic, or systemic diseases. 5. Other conditions deemed by the investigator as unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Menstrual cycle status (including presence or absence of menstrual cycles, duration of menstruation, menstrual volume, etc.);The AMH level in peripheral blood;Gonadal hormone level;Number of antral follicles;

Secondary

MeasureTime frame
The duration of ovarian function maintenance;

Countries

China

Contacts

Public ContactLi Fei

The First Affiliated Hospital of Nanchang University

yx021021@sina.com+86 139 7003 8386

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026