Clinical Trial: A Study of Transrectal Ultrasound-Guided Oocyte Retrieval in Patients for Whom Transvaginal Oocyte Retrieval Is Not Feasible or Acceptable (Japan)

Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063103) titled 'Transrectal Oocyte Retrieval as an Alternative When Transvaginal Oocyte Retrieval Is Difficult or Not Acceptable' on Oct. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Saitama Medical Center Department of Obstetrics and Gynecology

Condition: Condition - Female infertility Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In recent years, the population of patients requiring fertility preservation has expanded to include adolescents and young adults (AYAs) with cancer, transgender and gender-diverse individuals, and patients with congenital vaginal agenesis. Accordingly, there is a growing need to establish alternative oocyte retrieval techniques for patients in whom transvaginal oocyte retrieval (TVOR) is difficult or not feasible. Transrectal oocyte retrieval (TROR), like TVOR, allows access to the ovaries from the vicinity of the ovaries and is therefore expected to achieve greater oocyte retrieval efficiency than the transabdominal approach. Although the safety and efficacy of TROR have been reported in other countries, no data are currently available in the Japanese population. This study is the first to introduce TROR in Japan and aims to evaluate its safety and feasibility. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Transrectal Oocyte Retrieval bowel preparation antibiotic prophylaxis

Eligibility: Age-lower limit - 16 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Women who wish to undergo oocyte retrieval for the purpose of fertility preservation or assisted reproductive technology. 2. Patients who wish to preserve the hymen, or in whom transvaginal oocyte retrieval is considered difficult for anatomical or medical reasons. 3. Patients who have received sufficient explanation regarding the study and have provided written informed consent voluntarily. Key exclusion criteria - 1. Patients with active rectal or anal disease, such as proctitis, perianal abscess, or severe hemorrhoids. 2. Patients with pelvic or systemic infection. 3. Patients with a bleeding tendency or those receiving anticoagulant therapy in whom safe needle puncture is considered difficult. 4. Patients in whom insertion of a transrectal ultrasound probe is considered difficult. 5. Patients whom the principal investigator considers unsuitable for participation in the study. Target Size - 5

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072240

Disclaimer: Curated by HT Syndication.