A Comparison of Cost - Effectiveness of Stimulated ICSI and IVM Strategy in PCOS Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- direct costs
研究概览
简要总结
In polycystic ovary syndrome (PCOS) patients, both in vitro maturation (IVM) and intra-cytoplasmic sperm injection (ICSI) are indicated as optional treatments. Although recently ICSI techniques have been reported as more successful the IVM in achieving pregnancy, they have also become much more expensive for the couples involved. Whilst most high-income countries offer Assisted Reproductive Technology (ART) procedures fully or partially paid by the government, the patients in low or middle-income countries have to cover self-fund infertility treatments. With limited resource, a study conducting based on the prevalence - based cost - effectiveness analysis is necessary for health managers, policy makers and especially to assist patients' decision making in these countries.
However, there are still limited published studies that have evaluated the cost-effectiveness of these strategies are available in the literature. This study is conducted based on the prevalence - based cost - effectiveness analysis from the patient's perspective. Activity - based costing method is used to cost in all levels of the healthcare system, which the patients have to pay directly or indirectly. It also analyses incremental cost - effectiveness to evaluate the cost - effectiveness of IVM and ICSI in PCOS women.
详细描述
A Cost - Effectiveness Analysis (CEA) Study:
- To identify, measure, and evaluate the cost of ICSI treatment and IVM treatment in PCOS patients, and the incremental cost of ICSI system implemented in PCOS patients.
- To quantify the effectiveness of ICSI treatment and the IVM through number and proportion of clinical pregnancy, live birth, and incremental effectiveness of the ICSI treatment implemented in PCOS patients.
- To determine the cost - effectiveness of ICSI treatment compared with IVM in PCOS patients.
- To measure the incremental cost - effectiveness of ICSI treatment implemented. The sample size for this study of 140 subjects, in both groups, being treated for 1 IVM or ICSI cycle is based upon the cost and the effectiveness (live birth rate).
METHODS Cost - Effectiveness Analysis (CEA) Activity - based costing method is used to cost in all levels of the healthcare system which the patients have to pay directly or indirectly for IVM or ICSI. This study also analyzes incremental cost - effectiveness to evaluate the cost - effectiveness of ICSI treatment implemented in PCOS patients.
Sensitivity analysis In this study, two techniques of sensitivity analysis below employing for the decision tree model, which is mentioned as below, are one - way sensitivity analysis and Probabilistic Sensitivity Analysis (PSA).
One - way sensitivity analysis with Tornado diagram will analyses and Probability sensitivity analysis with Monte Carlo simulation and Scatter plots of the difference in costs respecting with the difference in live birth gained will analyses if all parameters varying together simultaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Couples undergoing IVM or ICSI treatment for the 1st time.
- •Husband: total mobile sperm count over 10 million/ml (before washing) or over 2 million/ml (after washing) or normal semen analysis (WHO 2010 criteria).
- •Wife: PCOS patients (Rotterdam European Society of Human Reproduction and Embryology (ESHRE)/ American Society of Reproductive Medicine (ASRM) 2004 aged from 18 to 37 at the time of conducting IVM or ICSI.
- •Each subject must have results of clinical laboratory test (complete blood count (CBC), blood chemistries, and urinalysis, pap smear) within normal limits or clinically acceptable to the investigator, as measured by the local laboratory at screening.
- •Each subject must have results of a physical examination, including blood pressure, within normal limits or clinically acceptable limits to the investigator.
排除标准
- •The subject (wife) has a recent (i.e. within 3 years prior to conducting IVM or ICSI) history of/ or any current endocrine abnormality (irrespective whether the patient is stabilized on treatment).
- •The subject has a recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease requiring regular treatment.
- •Endometriosis (in uterine muscle, ovary or pelvis) or IVF/ICSI with donated sperm, donated eggs or IVM with donated sperm, clomiphene citrate resistant PCOS (PCOS), tubal factor (blocked fallopian tube, hydrosalpinx), abnormal uterine structure (submucosal fibroid or intramural fibroid ≥30 mm, uterine polyp, bicornuate uterus, didelphic uterus).
- •The subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by the local laboratory; results obtained within one year prior to conducting IVM or ICSI are considered valid).
- •The subject has contraindications for the use of gonadotropins (ex; tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, or ovarian cysts) or GnRH-antagonist (e.g. hypersensitivity, pregnancy/lactation).
- •The subject has known gene defects, genetic abnormalities, or abnormal karyotyping, relevant for the current indications or for the health of the offspring.
- •The subject smokes or has recently stopped smoking (ex. within the last 3 months).
- •The subject has a history or presence of alcohol or drug abuse within 12 months prior to conduct IVM or ICSI.
- •The subject has used any experimental drugs within 3 months prior to conduct IVM or ICSI.
- •The subject is participating in any other clinical study (excluding surveys).
- •Those who do not complete the process of IVM or IVF/ICSI (withdrawing, no embryo for transfer or embryos haven't been transferred).
结局指标
主要结局
direct costs
时间窗: 1 year
the costs (Vietnam dong) for medical services, medication, examinations, procedures, etc.
live birth
时间窗: 36 weeks
the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of the pregnancy, which, after such separation, breathes or shows any other evidence of life - e.g. beating of the heart, pulsation of the umbilical cord or definite movement of voluntary muscles - whether or not the umbilical cord has been cut or the placenta is attached. Each product of such a birth is considered live born (WHO).
indirect costs
时间窗: 1 year
the costs (Vietnam dong) for patients' working hour loss (income per one working hour x number of hours), transportation fee (by motorbike, car, bus, taxi, others), accommodation (including hotel, guest house, etc.).
次要结局
未报告次要终点
研究者
Manh Tuong Ho
Director
Vietnam National University