临床试验/2023-509919-89-00

2023-509919-89-00招募中4 期

RAndom sTArT Ovarian stimUlatIon (RSOS) in eLective oocyte cryopreservation cycLEs (RATATOUILLE): a single-center, non-inferiority, randomised controlled trial

UZ Brussel1 个研究点分布在 1 个国家目标入组 277 人开始时间: 2024年10月10日最近更新: 2025年2月5日

试验速览

阶段: 4 期
状态: 招募中
发起方: UZ Brussel
入组人数: 277
试验地点: 1
主要终点: Total number of mature cryopreserved oocytes per ovarian stimulation (OS) cycle in elective oocyte cryopreservation.

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of the current randomized controlled trial is to compare the efficacy of Random Start Ovarian Stimulation to conventional early follicular phase stimulation in Elective Oocyte Cryopreservation cycles.

入排标准

年龄范围: 18 years 至 64 years（18-64 Years）
性别: Female
接受健康志愿者: 否

入选标准

• Age from ≥ 25 to ≤ 39 years
• Body mass Index (BMI) ≥18 to < 30 kg/m2
• Signed informed consent
• Regular menstrual cycle length i.e. 24-35 days
• Patients who are not taking hormonal contraception or who stopped hormonal contraception at least 2 months ago
• Normally accessible ovaries/ ovary

排除标准

• Patients currently taking hormonal contraception (including intrauterine devices)
• Contraindications to the use of gonadotropins
• Endometriosis grade 3-4
• Patients with Anti-müllerian hormone (AMH) <0.5 ng/mL (Revelli et al., JARG 2016) or AMH >3.2 ng/mL (Roche Diagnostics PCOM)
• Any untreated endocrine abnormality

结局指标

主要结局

Total number of mature cryopreserved oocytes per ovarian stimulation (OS) cycle in elective oocyte cryopreservation.

次要结局

 The total number of oocytes retrieved
 Total consumption of gonadotropins (IU) used during Ovarian Stimulation
 Duration of Ovarian Stimulation, defined as the time from the first day of stimulation until the application of the trigger for the final oocyte maturation

研究者

发起方

UZ Brussel

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Michel De Vos

Scientific

UZ Brussel

研究点 (1)

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