Feasibility and Acceptability of Using a Semi-quantitative Pregnancy Test to Monitor hCG Levels After Assisted Fertility Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Proportion of SQPT results that accurately monitor pregnancy
研究概览
简要总结
Given the potential of semi-quantitative pregnancy tests as part of assisted fertility care, the investigators would like to document the feasibility and acceptability of a semi-quantitative pregnancy test as an adjunct to or replacement of current monitoring protocols to offer women and health care providers a new choice of diagnostic tools to confirm early pregnancy. The pilot will help us to better understand how this tool complements existing monitoring protocols. If a suitable addition or replacement to repeat blood draws for serum hCG assessment, the SQPT could also contribute to efforts to make assisted fertility treatments more patient-friendly. This study seeks to test this innovation by asking women assigned to perform a Quanti5 Multilevel hCG Pregnancy Test (Athenium Pharmaceuticals, LLC, Nashville, TN) at home on a weekly basis for up to 4 weeks after egg retrieval/embryo transfer or intrauterine insemination.
The investigators hypothesize that the test, which can be used at home by women, will provide confirmation of the presence of a pregnancy compared with standard serum hCG testing because 1) it has sensitivity and specificity that correlates well with serum testing, and 2) it can be used at home and thus earlier to determine presence of hCG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Planning embryo transfer or intrauterine insemination (IUI)
- •Agrees to return for a series of follow-up visits
- •Willing to follow provider instructions regarding use of at-home pregnancy test
- •Has not already participated in this study (each woman can only participate once)
- •Able to read and write in English
- •Willing to provide an address and/or telephone number to be contacted for purposes of follow-up
- •Willing and able to consent to study participation
排除标准
- •Does not agree to return for a series of follow-up visits
- •Not willing to follow provider instructions regarding use of at-home pregnancy test
- •Has already participated in this study (each woman can only participate once)
- •Not able to read and write in English
- •Not willing to provide an address and/or telephone number to be contacted for purposes of follow-up
- •Not willing and able to consent to study participation
结局指标
主要结局
Proportion of SQPT results that accurately monitor pregnancy
时间窗: 6 weeks
Participants will have follow-up visits that include serum hCG testing and ultrasounds to confirm pregnancy. Will be able to compare these results to the results of the at-home pregnancy test.
次要结局
- Effectiveness of written instructions and provider's counseling(6 weeks)
- Acceptability of semi-quantitative pregnancy test(6 weeks)
- Feasibility of women using this test at home(6 weeks)