Reproductive Outcomes in Children Born Through Assisted Reproduction (ART): Focus on Intracytoplasmic Sperm Injection (ICSI) With Surgically Retrieved Sperm.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 200,000
- 试验地点
- 1
- 主要终点
- Biochemical pregnancy rate
研究概览
简要总结
This research project explores how the source of sperm affects outcomes in assisted reproductive technologies (ART), focusing on children conceived through intracytoplasmic sperm injection (ICSI) with surgically retrieved sperm (SRS). Outcomes will be compared to those from ICSI with ejaculated sperm and conventional IVF. Using national registry data from all IVF and ICSI treatments in Sweden between 2007 and 2023 (Q-IVF), the study applies artificial intelligence (AI) and machine learning (ML) to identify factors influencing success rates. The aim is to improve prediction models and support more personalized fertility treatments. Special emphasis is placed on understanding the potential risks and long-term health outcomes for children conceived using SRS, which may be associated with higher rates of genetic abnormalities. The results may help optimize care strategies for infertile couples.
详细描述
This research project aims to improve our understanding of how different sources of sperm affect outcomes in assisted reproductive technologies (ART). The focus is on children conceived through intracytoplasmic sperm injection (ICSI) using surgically retrieved sperm (SRS), compared to ICSI with ejaculated sperm and conventional in vitro fertilization (IVF).
The study has three main goals:
- To compare reproductive outcomes following ICSI with SRS, ICSI with ejaculated sperm, and conventional IVF.
- To investigate whether artificial intelligence (AI) and machine learning (ML) algorithms can predict cumulative reproductive outcomes, including results from both fresh and frozen embryo transfer cycles.
- To evaluate how AI/ML-based models perform in comparison to traditional statistical methods in terms of accuracy and predictive value.
Method: National Population-Based Registry Study: This includes all IVF and ICSI treatments performed in Sweden from January 1, 2007, to December 31, 2023, using data from the Swedish National Quality Registry for Assisted Reproduction (Q-IVF). AI will be used to analyze large datasets, detect patterns, and help identify key factors-such as sperm source, number of retrieved oocytes, and patient characteristics-that may influence treatment success. This approach could lead to personalized treatment plans and better predictions of successful pregnancy outcomes.
Special attention is given to outcomes in children born after ICSI with surgically retrieved sperm, as these sperm may be less mature and carry a higher risk of genetic abnormalities. The findings are expected to provide valuable insights into the reproductive and long-term health outcomes of these treatments, ultimately helping to improve care and treatment strategies for infertile couples.
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 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All IVF treatments performed in Sweden during the study period.
- •IVF treatments will be identified from the National register Q-IVF.
排除标准
- •Children born from multiple pregnancies
- •Children conceived through oocyte and sperm donation
结局指标
主要结局
Biochemical pregnancy rate
时间窗: From enrollment to the end of treatment at 3 weeks
Positive urinary pregnancy test after fresh or frozen embryo transfer per embryo transfer.
Clinical pregnancy rate
时间窗: From enrollment to the end of treatment at 8 weeks.
Presence of gestational sac at ultrasound control after fresh or frozen embryo transfer per embryo transfer.
Live birth rate
时间窗: From enrollment to the end of treatment at delivery.
Live birth per embryo transfer after fresh and frozen embryo transfer.
次要结局
- Number of frozen embryos(From enrollment to the end of treatment at 5 days.)
- Miscarriage rate(From enrollment to the end of treatment before 22 weeks.)
研究者
Panagiotis Tsiartas
Associate Professor
Karolinska Institutet
