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

September 7, 2006 updated by: Hopital Antoine Beclere

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France, 49033
        • Recruiting
        • Angers Hospital
        • Contact:
        • Principal Investigator:
          • CATALA Laurent, MD
      • Clamart, France, 92140
        • Recruiting
        • Antoine Béclère Hospital
        • Contact:
        • Principal Investigator:
          • FERNANDEZ Hervé, PhD, MD
      • Créteil, France, 94000
        • Recruiting
        • Créteil Hospital
        • Contact:
        • Principal Investigator:
          • LÉONARD Franck, MD
      • Levallois-Perret, France, 92300
        • Recruiting
        • Franco-Britannique Hospital
        • Contact:
        • Principal Investigator:
          • MAIROVITZ Valérie, MD
      • Lille, France, 59037
        • Recruiting
        • Jeanne de Flandre Hospital
        • Contact:
        • Principal Investigator:
          • LUCOT Jean-Philippe, MD
      • Lyon, France, 69288
        • Recruiting
        • Hôtel Dieu
        • Contact:
        • Principal Investigator:
          • GOLFIER François, PhD
      • Marseille, France, 13005
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception
        • Contact:
        • Principal Investigator:
          • AGOSTINI Aubert, MD
      • Marseille, France, 13326
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille ; Hôpital Nord
        • Contact:
        • Principal Investigator:
          • BRETELLE Florence, PhD, MD
      • Nancy, France, 54042
        • Recruiting
        • Maternité régionale de Nancy
        • Contact:
        • Principal Investigator:
          • ESZTO Marie-Laure, MD
      • Nantes, France, 44093
        • Recruiting
        • Nantes Hospital
        • Contact:
        • Principal Investigator:
          • DARNIS Éric, MD
      • Paris, France, 75010
        • Recruiting
        • Lariboisière Hospital
        • Contact:
        • Principal Investigator:
          • FAZEL Afchine, MD
      • Paris, France, 75679
        • Recruiting
        • Cochin Hospital
        • Contact:
        • Principal Investigator:
          • CHOPIN Nicolas, MD
      • Poissy, France, 78303
        • Recruiting
        • Poissy Saint-Germain-en-Laye Hospital
        • Contact:
        • Principal Investigator:
          • BELOT Franck, MD
      • Roubaix, France, 59100
        • Recruiting
        • Roubaix hospital
        • Contact:
        • Principal Investigator:
          • LE GOUEFF Francoise, MD
      • Rouen, France, 76031
        • Recruiting
        • Charles Nicolle Hospital
        • Contact:
        • Principal Investigator:
          • RESCH Benoît, MD
      • Schiltigheim, France, 67303
        • Recruiting
        • CMCO
        • Contact:
        • Principal Investigator:
          • THOMA Véronique, MD
      • Tours, France, 37000
        • Not yet recruiting
        • Tours hospital
        • Contact:
        • Principal Investigator:
          • MARRET Henri, Ph D
      • Versailles, France, 78157
        • Recruiting
        • Versailles Hospital ; Hôpital André Mignot
        • Contact:
        • Principal Investigator:
          • RAYNAL Pierre, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Subsequent fertility with 2 years follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Complications of treatments
Time of hospitalisation
Decrease curve of beta-hCG after treatment
Success rate in each group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Antoine Beclere

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fernandez Hervé, PhD MD, Hôpital Antoine Béclère

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2004

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2006

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2006

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P030409/AOR03040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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