EUCTR2020-005914-16-BE进行中（未招募）1 期
COmbining Interventions of fertility preservation to Mitigate fertility loss after BReAst cancer - COIMBRA
niversitair Ziekenhuis Brussel0 个研究点目标入组 41 人开始时间: 2021年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Age 18-35 years
- •-BMI 18-35 kg/m²
- •-Diagnosis of breast cancer
- •-Presence of 2 ovaries
- •-Signed informed consent form
- •-Medically fit for general anesthesia (ASA score 1-3)
- •-Permission of oncology team (with agreement to postpone chemo/radiotherapy for at least 2 weeks)
- •-Random start controlled ovarian stimulation (follicular or luteal phase)
- •-AFC minimum (ie antral follicles measuring between 2-9 mm): 8 antral folli-cles
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 41
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Age <18 or >35 years
- •-BMI <18 or >35 kg/m²
- •-Difference in AFC between the ovaries of more than 7 antral follicles
- •-Diagnosis of PCOS
- •-Previous radiotherapy and/or chemotherapy (neo-adjuvant chemotherapy included)
- •-Endometriose rAFS 3-4
- •-Allergy or reaction to the use of Elonva®, Puregon®, Orgalutran®, Pregnyl® Gonapeptyl®, Decapeptyl® or letrozole in the past
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