An Observational Retrospective Cohort Trial on Low Prognosis Infertile Patient's Accessing IVF Cycle Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26,883
- 主要终点
- induction protocol type
研究概览
简要总结
The main objective of this study is to analyze management of Controlled Ovarian Stimulation (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.
详细描述
Humanitas Fertility Center maintains an external audit anonymized electronic research queries system, exported from a certified only access web database, which at time of this analysis (cycles at December 31th 2016) include 26,883 consecutive fresh non-donors IVF cycles. Patients who underwent these cycles had consented in writing that their medical records could be used for research purposes, as long as the patients' anonymity was protected and confidentiality of the medical record was assured. Since both of these conditions were met, this study has been approved on March 2th 2017 with an expedited review and approval protocol by the center's Institutional Review Board (IRB).
At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index; 18 ≤ BMI ≥ 27
- •Number of oocytes retrieved ≤ 9
- •Cycles performed between January 2010 - December 2015
排除标准
- •Age > 44
- •Number of oocytes retrieved ≥ 10
- •Abnormal uterine cavity
- •Endometriosis III-IV stage or adenomyosis
- •Testicular spermatozoa PGS (Preimplantation Genetic Screening) cycles
结局指标
主要结局
induction protocol type
时间窗: 6 years
number of antagonist and agonist protocols/ total numbers
次要结局
- Fertilization Rate(6 years)
- Pregnancy Rate(6 years)
- Live Birth Rate(6 years)
- Ongoing Pregnancy Rate(6 years)