Prospective Study, Randomized Controlled Trial Between Medical Treatment by Methotrexate Versus Conservative Surgical Treatment (Group 1) and Conservative Versus Radical Surgical Treatment (Group 2) to Evaluate Subsequent Fertility
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Hopital Antoine Beclere
- Enrollment
- 600
- Locations
- 36
- Primary Endpoint
- Subsequent fertility with 2 years follow-up
Study Overview
Brief Summary
Three protocols are used to treat ectopic pregnancies: medical treatment by methotrexate, conservative surgery or radical surgery. There are no data about subsequent fertility except in a cohort study. The investigators propose to evaluate the true subsequent fertility with a follow-up of 2 years, in a randomized controlled trial.
Detailed Description
The first group includes non active ectopic pregnancies defined by score or algorithm. In this case, we propose a randomized controlled trial between medical and conservative surgery. In all others clinical situations, we proposed surgery treatment. In a randomized controlled trial we compare conservative versus radical treatment. The patients are followed-up during 2 years with phone contact every 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis by ultra sound of ectopic pregnancy (EP)
- •Patients aged > 18 years old
- •Desire of future pregnancy
Exclusion Criteria
- •EP by failure of contraception
- •EP associated with in vitro fertilization (IVF)
Outcomes
Primary Outcomes
Subsequent fertility with 2 years follow-up
Secondary Outcomes
- Complications of treatments
- Time of hospitalisation
- Decrease curve of beta-hCG after treatment
- Success rate in each group