- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06505057
Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female Cancer Patients (HKCH)
Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To date, transplantation of cryopreserved ovarian tissue has resulted in births of at least 130 children but data on transplantation of ovarian tissue removed before puberty are scarce.
During ovarian tissue cryopreservation (OTC), it is possible to freeze isolated oocytes. In 2003, Revel et al described for the first time oocyte isolation in children younger than 12 years with seven, eight and seven oocytes isolated from the ovarian cortex of patients aged 5, 8 and 10 years, respectively.
At this moment, financial constraint is another great hindrance to fertility preservation in Hong Kong as the procedure is not cheap. Cryopreservation of gametes and embryos involving assisted reproductive technology is expensive and the costs of fertility preservation impose a great burden to these cancer patients on top of the great expenses for their chemo- or radiotherapy. It is almost impossible for underprivileged families.
Young cancer patients may often need immediate gonadotoxic treatment for their cancer, just like those with haematological cancers. In these patients, egg or embryo freezing is not possible as it takes at least 8-12 days' time for ovarian stimulation. Ovarian tissue freezing is an ideal option for these patients as it can be performed immediately and does not need any time for ovarian stimulation. We hope we can develop this service in our locality to allow more young female cancer patients to have their fertility preserved.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elaine NG, MPhil
- Phone Number: 35052745
- Email: elaineng@cuhk.edu.hk
Study Locations
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-
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Hong Kong, Hong Kong
- Recruiting
- Hong Kong Children's Hospital
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Contact:
- Elaine NG, MPhil
- Phone Number: 35052745
- Email: elaineng@cuhk.edu.hk
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Contact:
- Jacqueline Pui Wah CHUNG, MBBS
- Phone Number: 35051537
- Email: acquelinechung@cuhk.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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)
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical complications
Time Frame: 15 years
|
Surgical complications after ovarian tissue transplantation
|
15 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnancy rate
Time Frame: 15 years
|
Pregnancy rate after ovarian tissue transplantation
|
15 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacqueline Pui Wah CHUNG, MBBS, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAED-2023-079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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