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Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00137982
Enrollment
600
Registered
2005-08-30
Start date
2004-08-31
Completion date
2008-07-31
Last updated
2006-09-08

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

Conditions

Tubal Pregnancy

Keywords

Ectopic pregnancy, Surgical treatment, Medical treatment, Fertility

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.

Interventions

PROCEDURETreatment of ectopic pregnancy

Sponsors

Hopital Antoine Beclere
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
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)

Design outcomes

Primary

MeasureTime frame
Subsequent fertility with 2 years follow-up

Secondary

MeasureTime frame
Complications of treatments
Time of hospitalisation
Decrease curve of beta-hCG after treatment
Success rate in each group

Countries

France

Contacts

Primary ContactFernandez Hervé, PhD MD
herve.fernandez@abc.aphp.fr+33 1 45 37 44 69

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026