Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062447) titled 'A Study of Freezing and Reimplanting a Patient's Own Ovarian Tissue to Preserve Future Fertility' on Aug. 3.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Hokkaido University

Condition: Condition - Malignant neoplasms and immune diseases associated with a high risk of fertility impairment, and premature ovarian insufficiency Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy and safety of ovarian tissue cryopreservation and autologous transplantation for fertility preservation in patients with malignant neoplasms or immune diseases whose treatment is associated with a high risk of fertility impairment, and in patients with premature ovarian insufficiency. The primary outcome is the live birth rate after autologous ovarian tissue transplantation. Clinical pregnancy, ovarian graft function, perioperative complications, neonatal outcomes, and effects on the underlying disease will also be evaluated. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Within 60 days after enrollment, laparoscopic unilateral oophorectomy will, in principle, be performed under general anesthesia. The ovarian cortex will be cut into tissue fragments approximately 10 x 10 mm in size and 1 mm in thickness and cryopreserved using the vitrification method. If oocytes are retrieved by follicular aspiration, they will also be cryopreserved using the vitrification method. After completion of treatment for the underlying disease, cryopreserved ovarian tissue will be thawed and transplanted laparoscopically if the physician treating the underlying disease determines that transplantation is permissible and the patient wishes to undergo the procedure. In principle, orthotopic transplantation onto the surface of the remaining ovary will be performed. If no residual ovary is present, heterotopic transplantation will be performed at a site such as the retroperitoneum near the ovary. Retransplantation of the remaining cryopreserved tissue may be performed as needed.

Eligibility: Age-lower limit - Not applicable Age-upper limit - 43 years-old > Gender - Female Key inclusion criteria - Aged under 43 years at the time of informed consent for ovarian tissue cryopreservation. Has a malignant neoplasm, hematologic malignancy, immune disease, or other condition whose treatment is associated with a high risk of fertility impairment, or has premature ovarian insufficiency, and wishes to undergo fertility preservation. Has no ovarian lesion associated with the underlying disease. Is medically fit to undergo oophorectomy. Has a reasonable prospect of cure and long-term survival from the underlying disease. Written informed consent has been obtained from the patient or a legally acceptable representative. Assent will be obtained from minors whenever possible. Key exclusion criteria - Oophorectomy is expected to interfere with treatment of the underlying disease. The investigator considers the patient unsuitable for participation in the study. Target Size - 150

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 04 Month 16 Day Date of IRB - 2024 Year 04 Month 16 Day Anticipated trial start date - 2024 Year 09 Month 01 Day Last follow-up date - 2046 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071431

Disclaimer: Curated by HT Syndication.