Comparison of treatment effect of fixed and non-fixed interval prescription of Actinomycin-D on ß-HCG level among patients with low-grade gestational trophoblastic neoplasia

Comparison of treatment effect of fixed and non-fixed interval prescription of Actinomycin-D on ß-HCG level among patients with low-grade gestational trophoblastic neoplasia: a double blind randomized clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201706199014N170

Enrollment

Registered

2017-06-26

Start date

2017-06-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Trophoblastic neoplasia. Hydatidiform mole, unspecified

Interventions

Intervention 1: Intervention group 1: Actinomycin-D 1.25 mg per/square meter every 2 weeks for 3 months. Intervention 2: Intervention group 2: Actinomycin-D 1.25 mg per/square meter based on ß-HCG lev

Treatment - Drugs

Intervention group 1: Actinomycin-D 1.25 mg per/square meter every 2 weeks for 3 months.

Intervention group 2: Actinomycin-D 1.25 mg per/square meter based on ß-HCG level for 3 months.

Eligibility

Sex/Gender

Female

Age

16 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age of 16 to 50 years; low-grade gestational trophoblastic neoplasia; no response to methotrexate. Exclusion criteria: Pregnancy or breastfeeding; history of herpes or chicken Pox infection; liver or kidney or bone marrow disorder.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Measuring the serum level ß-HCG. Timepoint: before intervention and every week for 1 month and then monthly for 3 months and then every 2 months for 6 months. Method of measurement: through laboratory test.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Somayeh Heidari

Fatemieh Hospital

drsrezvan@gmail.com+98 81 3828 3939

Outcome results

None listed

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