Anti-TNFα Therapy Before Frozen Blastocyst Transfer Might Improve the Clinical Pregnancy Rate for Endometriosis Infertile Women With a Previously Failed ICSI Procedure. A Preliminary Clinical Assessment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
研究概览
简要总结
This prospective study targets infertile women with endometriosis (EM) who have experienced a previously failed Intracytoplasmic Sperm Injection (ICSI) trial. Using the P-I-C-O framework, the study evaluates whether the administration of an anti-TNF-α therapy (Intervention) 4-5 days before a frozen blastocyst transfer (FBT) improves reproductive outcomes compared to standard protocols (Comparison). The primary outcome is the clinical pregnancy rate, with secondary outcomes focusing on implantation, ongoing pregnancy, and neonatal health. The goal is to determine if mitigating pro-inflammatory cytokines like TNF-α can enhance endometrial receptivity in this specific high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
There was no masking or blinding involved in this study. Both the participants and the investigators/clinicians were aware that the anti-TNFα therapy was being administered. This is common in preliminary clinical assessments where the goal is to evaluate the feasibility and initial efficacy of a specific medical intervention.
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Endometriosis diagnosed during infertility workup.
- •History of a previously failed ICSI trial.
- •Presence of more than one frozen embryo at the D-5 blastocyst stage qualified as good quality (Grade AA6).
- •Signed informed consent.
排除标准
- •Polycystic Ovary Syndrome (PCOS).
- •Inflammatory disorders other than endometriosis.
- •Currently maintaining immune-modulating therapies for any other cause.
- •Refusal to participate.
研究组 & 干预措施
Intervention Group
73 infertile women with endometriosis and a history of failed ICSI.
干预措施: TNF-α Inhibitor (Drug)
Intervention Group
73 infertile women with endometriosis and a history of failed ICSI.
干预措施: Frozen Blastocyst Transfer (FBT) (Procedure)
Control Group
72 infertile women with endometriosis and a history of failed ICSI.
干预措施: Frozen Blastocyst Transfer (FBT) (Procedure)
结局指标
主要结局
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
时间窗: 4-6 weeks post-transfer.
The proportion of patients who achieved a clinical pregnancy (confirmed by ultrasound visualization of a gestational sac with fetal heart activity) following frozen blastocyst transfer, reflecting the effectiveness of the administered anti- TNFα therapy.
次要结局
- Success Rate of Treatment in Achieving Healthy Neonatal Outcomes.(At the time of delivery (approximately 9 months post-transfer).)
研究者
Basma Sakr
Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University
Benha University