Comparison of Live Birth Rates in Patients With Immune Overactivation Receiving Glucocorticoids With or Without Prior Sensitivity Testing: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Live Birth Rate After First Embryo Transfer
研究概览
简要总结
This retrospective single-center observational cohort study evaluates live birth rates after the first embryo transfer following immune assessment in infertile women with documented uterine immune overactivation.
In routine clinical practice, glucocorticoids represent first-line therapy for immune overactivation. Some patients underwent glucocorticoid sensitivity testing prior to embryo transfer based solely on standard clinical practice and patient preference. In cases of demonstrated glucocorticoid resistance, alternative therapeutic strategies were implemented according to usual care.
The study analyzes clinical data collected between September 2020 and November 2025 to assess the association between prior glucocorticoid sensitivity testing and live birth rate after the first fresh or frozen blastocyst transfer performed following immune evaluation.
No treatment allocation was determined by a study protocol.
详细描述
This retrospective single-center cohort study was conducted at Hôpital Pierre Rouquès - Les Bluets (Paris, France) and includes infertile women aged 40 years or younger undergoing in vitro fertilization (IVF) between September 2020 and November 2025.
All included patients had documented uterine immune overactivation identified through routine immune assessment prior to embryo transfer. In standard clinical practice at our center, glucocorticoids represent first-line therapy for immune overactivation.
Some patients underwent glucocorticoid sensitivity testing prior to embryo transfer, based solely on routine clinical practice and patient preference. In cases of demonstrated glucocorticoid resistance, alternative therapeutic strategies were implemented according to standard care.
The study compares live birth rates following the first fresh or frozen blastocyst transfer performed after immune evaluation in patients managed with or without prior glucocorticoid sensitivity testing.
This study is purely observational and retrospective. No treatment allocation or testing decision was determined by a study protocol.
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
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile patients undergoing IVF with planned fresh or frozen embryo transfer
- •Age ≤ 40 years at the time of the transfer
- •Documented uterine immune over-activation
- •Treatment with glucocorticoids in routine clinical practice, with or without prior glucocorticoid sensitivity testing
- •Fresh or frozen blastocyst transfer performed within 9 months following immune assessment at Hôpital des Bluets
排除标准
- •• Age > 40 years
- •No available uterine immune profile
- •Normal immune profile or immune underactivation
- •Management exclusively with alternative therapeutic strategies (e.g., low molecular weight heparin [LMWH], intralipid therapy) or combination therapies (e.g., LMWH + glucocorticoids or intralipid + glucocorticoids)
- •Embryo transfer performed more than 9 months after immune assessment
- •Cleavage-stage embryo transfer
- •Embryo transfer performed in another center
- •Oocyte donation IVF cycles
研究组 & 干预措施
No Sensitivity Testing
Patients with documented uterine immune overactivation managed with first-line glucocorticoid therapy in routine clinical practice without prior glucocorticoid sensitivity testing.
Sensitivity Testing
Patients with documented uterine immune overactivation who underwent glucocorticoid sensitivity testing prior to embryo transfer. In cases of glucocorticoid resistance, alternative therapeutic strategies were implemented according to routine clinical practice.
结局指标
主要结局
Live Birth Rate After First Embryo Transfer
时间窗: From first embryo transfer to delivery (up to approximately 9 months)
Live birth defined as delivery of a viable infant beyond 24 weeks of gestation, assessed after the first fresh or frozen blastocyst transfer performed following immune evaluation.
次要结局
- Clinical Pregnancy Rate(Time Frame: 6-8 weeks after embryo transfer)
- Implantation Rate(: 6-8 weeks after embryo transfer)
- Ongoing Pregnancy Rate(10 weeks after embryo transfer)
- Miscarriage Rate per Clinical Pregnancy(Up to 24 weeks of gestation)