跳至主要内容
临床试验/CTRI/2025/12/099950
CTRI/2025/12/099950尚未招募不适用

Augmented intelligent clinical support systems to aid decision-making for pregnancy outcomes after In-Vitro Fertilisation or Intracytoplasmic sperm injection

Indian Council of Medical Research3 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
8,000
试验地点
3
主要终点
Development of interoperable common data model

研究概览

简要总结

One of the biggest challenges of managing a fertility clinic is handling large amounts of data. Managing In-Vitro Fertilisation (IVF) treatments by using augmented intelligent systems makes it easy to enter and organize data about the patients, their treatments, the tests performed, equipment used, manage appointments & schedules as well as audit the  IVF results for quality assurance purposes. There is a felt need for a uniform digitalization system to allow to consolidation of information from various sources present in an IVF clinic such as labs, operating rooms, ultrasound rooms, consulting rooms, and registration desks which are both accessible and highly secure.

.In the last decade, the demand for Assisted Reproductive Technologies(ART) has significantly increased with India contributing to one of the highest growths in the number of ART centres and number of cycles per year (1). Despite having planned a national ART registry after the latest ART Act 2021, there is a lack of uniform data reporting system across all centres in India. There is no clinical prediction model available from India to predict success rates after IVF. Considering several individual patient variables and characteristics of treatment received in the past that may affect IVF outcomes, it is difficult and inappropriate to do generalised counselling regarding success rates after a complete IVF cycle. Thus, it becomes critical to individualise the counselling of each couple which further needs to be revised after one or more cycles for improved counselling and decision making.

Therefore, this study proposes to develop an augmented intelligent system suited to meet patient daily requirements and keep patient data organised to deliver the best quality care as well as create a unform clinical registry.

研究设计

研究类型
Observational

入排标准

年龄范围
21.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • All women who underwent IVF cycle in past 12 years and within subsequent 2 years after approval of the project
  • Complete follow up available till live birth or until the last complete cycle.

排除标准

  • Patients with incomplete data records.

结局指标

主要结局

Development of interoperable common data model

时间窗: 12 months

次要结局

  • 1. Number of visits per patient(2. Time duration from decision of IVF to initiation of ovarian stimulation)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr. Neena Malhotra

All India Institute of Medical Sciences, New Delhi

研究点 (3)

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