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Recruiting NCT05830929

Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female Cancer Patients

No phase Interventional Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ovarian tissue freezing and subsequent auto-transplantation after thawing.
Who it may be relevant to
Registry conditions: Neoplasms. Basic parameters: 1 months — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Ovarian Tissue Cryopreservation will be provided to cancer patients to allow them to have their fertility preserved.

Detailed description

This project hopes to provide Ovarian Tissue Cryopreservation to patients who do not have adequate time for ovarian stimulation in oocyte or embryo freezing and in prepubertal girls where oocyte freezing is not possible. All the patients will have fertility preservation consultations with a fertility specialist in our unit to go through the details of ovarian Tissue Cryopreservation service and risks related to ovarian tissue cryopreservation procedures. After undergoing ovarian tissue collection via surgery, the collected ovarian tissue will be cryopreserved either by slow freezing or vitrification in our unit.

Interventions

  • Procedure Ovarian tissue freezing and subsequent auto-transplantation after thawing
    Removal of the ovarian tissue will be retrieved via laparoscopic surgery under general anesthesia. The ovarian cortical tissue obtained will be transferred on ice to the laboratory for cryopreservation. After medical treatment, if the patient would like to start a family but has experienced premature ovarian failure, she will have ovarian tissue auto-transplantation after thawing.

Primary outcome measures

  • Surgical complications [Time frame: 15 years]
Secondary outcome measures (1)
  • Pregnancy rate [Time frame: 15 years]

Eligibility criteria

Inclusion criteria

  • Patients aged from 0-35 years old and diagnosed with cancer e.g., leukaemia, myeloproliferative or myelodysplastic diseases, lymphoma, bone tumours, neurological neoplasms and sarcoma, Paediatric bone marrow transplant patients
  • Patients with any illness or who will undergo any type of treatment that may cause irreversible damage to their fertility, such as extensive abdominal surgery, high toxicity medication and treatments;
  • Patients suffering from hormone-sensitive malignancies who will undergo medical treatment, such as radiotherapy and chemotherapy that is liable to damage their ovaries and deter them from conception in the future.

Exclusion criteria

  • Patients with no anticipated oncologic therapies
  • Patients who are pregnant
  • Children with one ovary
  • Children deemed high risk for perioperative complications
  • Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Hong Kong

Identifiers

NCT: NCT05830929 · 2023.096-T

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗