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

• Sponsor: Chinese University of Hong Kong (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05830929
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 248
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Procedure: Ovarian tissue freezing and subsequent auto-transplantation after thawing	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female Cancer Patients
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Apr 30, 2043
• Anticipated Study Completion Date: Dec 30, 2043

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Ovarian tissue freezing and subsequent auto-transplantation after thawing Ovarian tissue freezing and subsequent auto-transplantation after thawing

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.

Outcome Measures

Primary Outcome Measures

1. Surgical complications [15 years]

   Surgical complications after ovarian tissue transplantation

Secondary Outcome Measures

1. Pregnancy rate [15 years]

   Pregnancy rate after ovarian tissue transplantation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince of Wales Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• Chinese University of Hong Kong

Investigators

• Principal Investigator: Jacqueline Pui Wah CHUNG, MBBS, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chung Pui Wah Jacqueline, Associate Professor, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT05830929
• Other Study ID Numbers: 2023.096-T
• First Posted: Apr 26, 2023
• Last Update Posted: Apr 26, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 26, 2023