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Active, not recruiting

NCT Number: NCT07842796

Sequential vs. Combined Letrozole and Methotrexate for Tubal Ectopic Pregnancy.

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

24 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Benha university

Banhā, El Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

letrozole

Drug

Oral Letrozole 5 mg/day (2 times 2.5{ mg} tablets daily) for 4 days. If serum beta-hCG drops by >10% on Day 4, Letrozole is continued.

methotrexate

Drug

A single intramuscular injection of Methotrexate (50mg/m) is administered as rescue therapy, If beta-hCG drop is <10 on Day 4,

Primary outcomes

  1. Letrozole Standalone Success Rate

    Time frame: 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

Secondary outcomes

  1. Avoidance of Surgery

    Time frame: 19 days post-initiation oftreatment treatment.

    : Resolution of ectopic pregnancy (beta-hCG < 15 IU/L) using medical management alone, avoiding conversion to emergency surgery (salpingectomy/salpingotomy).

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Minimizing Surgical Intervention in Tubal Ectopic Pregnancy: A Randomized Comparison Between Sequential and Combined Letrozole and Single-Dose Methotrexate Regimens.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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