Effectiveness of the combination of gefitinib and methotrexate compared to methotrexate alone in the treatment of ectopictubal pregnancy

Effectiveness of the combination of gefitinib and methotrexate compared to methotrexate alone in the treatment of ectopictubal pregnancy: a multi-center,double- blind,placebocontrolled and randomised trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230722058884N3

Enrollment

Registered

2025-10-12

Start date

2025-10-11

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ectopictubal pregnancy. Ectopic pregnancy

Interventions

Intervention 1: Intervention group: 40 women with tubal ectopic pregnancy will receive a single dose of intramuscular methotrexate (50 mg/m2) and oral gefitinib (250 mg/day) for 7 days. Intervention 2

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: All women with a diagnosis of ectopic pregnancy are candidates for methotrexate treatment Age range 18 to 50 years Serum hCG concentration 1000-10000 L/IU before treatment.

Exclusion criteria

Exclusion criteria: Having a malignancy Patients undergoing chemotherapy or radiotherapy Intra-abdominal bleeding before intervention based on ultrasound findings

Design outcomes

Primary

Measure	Time frame
Need for surgery (salpingectomy or salpingostomy with laparoscopy or laparotomy) and hCG levels. Timepoint: hCG levels will be measured at the beginning of the study, 4 and 7 days after the start of treatment. Method of measurement: The hCG level will be assessed by testing and taking a blood sample.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomayeh Rezaei

Iran University of Medical Sciences

maryam.fakehi@gmail.com+98 21 5560 6034

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026