Evaluation of in Vitro Fertilisation Patients' Experience With a Personalized Prognostic Counseling Strategy and Its Impact on Treatment Utilization and Discontinuation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 366
- 试验地点
- 3
- 主要终点
- Treatment utilization (conversion) rate in the two groups
研究概览
简要总结
This study will be conducted in two phases. In the first phase, research subjects will be assigned to receive standard counseling. In the second phase, research subjects will receive Univfy counseling.
详细描述
Study period: 6 months plus 12 months follow-up. Participating centers: Ginefiv Madrid and Barcelona Inclusion / Exclusion criteria: See the Section on Inclusion and Exclusion Criteria.
In the first three months of the study, the participants (consenting patients) will be counseled as per standard care during their consultations ("Phase 1: Standard Counseling"). They will be asked to complete an anonymous online questionnaire to assess their experience after the consultation.
In the following 3 months of the study ("Phase 2: Univfy Report"), the participants (different from participants recruited in Phase 1) will instead be counseled with the Univfy PreIVF report during their initial consultation or subsequent consultations (as soon as a Univfy PreIVF report can be generated). They will be asked to complete an anonymous online questionnaire to assess their experience after the consultation.
During the following 12 months ("Phase 3: Outcomes Data Collection Period"), we will measure 1) patient experience based on patients' responses to the anonymous online questionnaire 2) IVF and intrauterine insemination (IUI) treatment utilization rates within 6 and 12 months, 3) patient retention rates after the first failed treatment attempt, 4) IUI-live birth rates and the cumulative live birth delivery rate (CLBdR, defined according to ICMART). The above metrics will be compared between participants who received conventional counseling versus those who received the Univfy report.
Outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients between 18-43 in age and their healthcare providers have determined that IVF treatment using the patients' own eggs is indicated.
排除标准
- •specific to this study only (these are not contraindications to using the Univfy® PreIVF Report):
- •Same sex couples
- •Patients undergoing DuoStim and/or PGT-M/-SR
- •Patients considering egg freezing rather than IVF
- •Patients considering the use of donor eggs or gestational carrier
- •Patients with contraindications to receiving the Univfy® PreIVF Report For Patients Under 40 Using Their Own Eggs. Those contraindications are:
- •Patients who are perimenopausal or menopausal
- •Patients who have very poor IVF results in the past, including:
- •extremely poor oocyte/embryo quality, no embryos to transfer,
- •no euploid embryos on PGT-A, no blastocysts in extended culture
结局指标
主要结局
Treatment utilization (conversion) rate in the two groups
时间窗: A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data up to the 6 months following the end of Phase 2 will be performed .
The treatment conversion rate refers to the proportion of patients who initiate IVF treatment after undergoing the initial consultation and counseling. This outcome will be compared between the two groups.
Retention Rate
时间窗: A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data up to the 6 months following the end of Phase 2 will be performed
This outcome measures the proportion of patients who continue with IVF treatment attempts after facing an unsuccessful first cycle.
Patient experience responses
时间窗: A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data up to the 6 months following the end of Phase 2 will be performed
Research satisfaction topics related to counseling about IVF treatment and IVF treatment success probability on a scale of 1-5: Consultation met expectations Satisfied with explanation of consent Felt listened to by your physician Satisfied with physician's explanation of treatment needed Satisfied with physician's explanation of medications needed and possible side effects Satisfied with clarity of physician's explanation of probability of IVF success Satisfied with material given to explain probability of IVF success Your physician's clarity and honesty about your probability of IVF success Do you think receiving information about your chances of treatment failure will help you to cope with the whole treatment.
Validation of Univfy prediction upon CLBdR
时间窗: A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data (e.g. positive serum HCG, fetal sac on ultrasound, fetal heart on ultrasound) up to the 6 months following the end of Phase 2 will be performed . Study follow up
This outcome assesses the accuracy of the Univfy model's predictions regarding cumulative live birth delivery rate (CLBdR). It compares the predicted CLBdR for each patient group with their actual CLBdR after completing the treatment cycle.
Time to Pregnancy
时间窗: A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data up to the 6 months following the end of Phase 2 will be performed .
This outcome tracks the duration it takes for a patient to achieve pregnancy after the initial and second consultation.
次要结局
- Self-reported satisfaction related to psychological support and cost of treatment(A full 12 months of follow up starting at the end of Phase 2. An interim analysis using data up to the 6 months following the end of Phase 2 will be performed .)