Ovarian tissue cryopreservation as fertility preservation after childhood cancer treatment followed by long-term observation after storage.

JRCT ID: jRCT1050220005

Registered date:22/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cancer in children and AYA
• Date of first enrollment: 15/04/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Before the initiation of treatments for childhood cancer, one side of the ovary is surgically removed and then cryopreserved. Patients regularly visit a long-term follow-up center after cancer treatment and have an opportunity for receiving information about ovarian tissue cryopreservation and autologous ovarian transplantation depending on their developmental stage. Physicians will perform autologous ovarian transplantation or give information about it.

Outcome(s)

• Primary Outcome: The implementation rate of autologous ovarian transplantation among patients who underwent ovarian tissue cryopreservation.

Secondary Outcome

1. Days of hospital stay for ovarian tissue cryopreservation and autologous ovarian transplantation.
2. Incidence of complications associated with ovarian tissue cryopreservation and autologous ovarian transplantation.
3. 10-year overall survival of patients who underwent ovarian tissue cryopreservation.
4. Pregnancy rate and production rate after autologous ovarian transplantation.
5. Recovery rate of endocrine function after autologous ovarian transplantation.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Diagnose as childhood cancer or disease requiring hematopoietic stem cell transplantation.
2. Without previous chemotherapy and radiotherapy, or with previous treatments which minimally affect ovarian function.
3. Cancer treatments which expected to cause ovarian dysfunction at a high rate are planned.
4. Expected to survive 5-year after cancer treatment (Probability does not matter)
5. Not eligible for other fertility-preserving treatments.
6. One side of the ovary is retained even after ovariectomy.
7. Delay in initiation of cancer treatment due to OTC does not affect cancer outcome.
8. Written informed consent has been obtained from the patients and/or their guardians.

Exclude criteria

1. Clear tumor infiltration or metastasis to the ovary.
2. Severe ovarian dysfunction at the time of ovarian tissue cryopreservation because of cancer treatments, etc.
3. No uterus due to tumor resection, etc., or severe uterus dysfunction will be expected due to cancer treatments.
4. Severe neurocognitive impairment is observed or will be expected after cancer treatments.

Related Information

• Primary Sponsor: Fujisaki Hiroyuki