NL-OMON47054招募中不适用
BRCA mutations and Ovarian ageing in women applying for in vitro fertilization and preimplantation genetiC diAgnosis - BROCA-2 sudy
niversitair Medisch Centrum Utrecht0 个研究点目标入组 109 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 109
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Case group:
- •Female age * 40 years
- •Regular menstrual cycles (i.e. mean cycle length of 21-35 days)
- •First IVF with ICSI and PGD treatment cycle due to a female pathogenic BRCA mutation
- •Written informed consent;Control group:
- •Female age * 18 years and * 40 years
- •Regular menstrual cycles (i.e. mean cycle length of 21-35 days, with the next menstrual period predictable within a 7 days* time frame)
- •First IVF with ICSI and PGD treatment cycle due to an indication unsuspected for reduced ovarian reserve status
- •Written informed consent
排除标准
- •Case group:
- •Ovarian surgery
- •Chemotherapy
- •Radiation therapy to the pelvis, lower abdomen or total body radiation
- •Known female endocrine or autoimmune abnormalities (i.e. Cushing syndrome, type I Diabetes Mellitus, hypothyroidism, hyperprolactinemia, adrenal insufficiency, hypoparathyriodism, myasthenia gravis, rheumatoid arthritis, systemic lupus erythematosus)
- •Body Mass Index > 30 kg/m2
- •Polycystic Ovarian Syndrome (Rotterdam criteria)
- •Early follicular FSH > 15 IU/L
- •Known HIV infection
- •Known genetic abnormalities, suspected for subfertility (structural or numerical abnormalities of the X-chromosome (i.e. Turner*s syndrome, fragile X syndrome), or abnormalities of human autosomal functionally relevant genes suspected for subfertility, other than a BRCA mutation. ;Control group:
- •Ovarian surgery
- •Chemotherapy
- •Radiation therapy to the pelvis, lower abdomen or total body radiation
- •Known female endocrine or autoimmune abnormalities (i.e. Cushing syndrome, type I Diabetes Mellitus, hypothyroidism, hyperprolactinemia, adrenal insufficiency, hypoparathyriodism, myasthenia gravis, rheumatoid arthritis, systemic lupus erythematosus)
- •Body Mass Index > 30 kg/m2
- •Polycystic Ovarian Syndrome (Rotterdam criteria)
- •Early follicular FSH > 15 IU/L
- •Known HIV infection
- •Known genetic abnormalities, suspected for subfertility (structural or numerical abnormalities of the X-chromosome (i.e. Turner*s syndrome, fragile X syndrome), or abnormalities on human autosomal functionally relevant genes suspected for subfertility.
- •PGD requested for structural chromosomal abnormalities
研究者
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