Minimizing Surgical Intervention in Tubal Ectopic Pregnancy: A Randomized Comparison Between Sequential and Combined Letrozole and Single-Dose Methotrexate Regimens.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Letrozole Standalone Success Rate
研究概览
简要总结
This study evaluates two medical strategies designed to minimize surgical intervention and reduce methotrexate (MTX) exposure in women with undisturbed tubal ectopic pregnancy (TEP). Participants with undisturbed TEP and pre-treatment serum $\beta$-hCG levels $<3500\text{ IU/L}$ are randomized to receive either a sequential regimen (initial letrozole monotherapy, reserving MTX only for treatment non-responders) or a combined regimen (simultaneous letrozole and single-dose MTX from day one). The study aims to compare the overall success rate of resolving TEP without emergency surgery, as well as the ability of the sequential approach to avoid MTX administration altogether.
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
- Single (Participant)
入排标准
- 年龄范围
- 24 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: Confirmed undisturbed/intact unilateral tubal ectopic pregnancy (TEP) presenting with lower abdominal pain and absence of vaginal bleeding.
- •Pre-treatment beta-hCG Level: Baseline serum beta-human chorionic gonadotropin (beta-hCG) level of less than 3,500 IU/L.
- •Ectopic Mass Dimensions: Gestational mass with a maximum diameter of less than 3.5 cm measured on transvaginal ultrasonography (TVU).
- •Ultrasound Integrity: Absence of transvaginal ultrasound features indicating hemoperitoneum or active intraperitoneal bleeding.
- •Informed Consent: Willingness to comply with follow-up schedules and provision of written informed consent.
排除标准
- •Disturbed Ectopic Pregnancy: Clinical, laboratory, or ultrasound evidence of tubal rupture, hemoperitoneum, or active intra-abdominal hemorrhage.
- •Elevated beta-hCG: Serum beta-hCG levels equal to or exceeding 3,500 IU/L at baseline.
- •Mass Size: Gestational mass diameter > 3.5 cm.
- •Contraindications to Methotrexate or Letrozole: Known hypersensitivity or contraindications to therapy (e.g., active hepatic, renal, or hematological dysfunctions).
- •Non-compliance: Inability or unwillingness to comply with the serial post-treatment beta-hCG monitoring and follow-up protocol.
研究组 & 干预措施
Combined Protocol
Participants in this arm receive simultaneous dual drug therapy starting on Day 1
干预措施: Methotrexate (Drug)
Sequential Protocol
Participants in this arm initially receive oral Letrozole at a dose of 5 mg daily (administered as two 2.5 mg film-coated tablets once daily) for 4 consecutive days. On Day 4, serum beta-hCG levels are evaluated to specify if rescue needed we will give a single intramuscular rescue injection of Methotrexate (50mg/m) while continuing Letrozole for an additional 7 days.
干预措施: Methotrexate (Drug)
Combined Protocol
Participants in this arm receive simultaneous dual drug therapy starting on Day 1
干预措施: Letrozole (Drug)
Sequential Protocol
Participants in this arm initially receive oral Letrozole at a dose of 5 mg daily (administered as two 2.5 mg film-coated tablets once daily) for 4 consecutive days. On Day 4, serum beta-hCG levels are evaluated to specify if rescue needed we will give a single intramuscular rescue injection of Methotrexate (50mg/m) while continuing Letrozole for an additional 7 days.
干预措施: Letrozole (Drug)
结局指标
主要结局
Letrozole Standalone Success Rate
时间窗: 19 days post-initiation oftreatment treatment.
Resolution of tubal ectopic pregnancy (confirmed by TVU and beta-hCG \< 15 IU/L) achieved via Letrozole monotherapy without requiring Methotrexate or surgical intervention
次要结局
- Avoidance of Surgery(19 days post-initiation oftreatment treatment.)
研究者
Basma Sakr
Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University
Benha University