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

Unknown

Conditions

Tubal Pregnancy

Intervention / Treatment

Procedure: Treatment of ectopic pregnancy

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

Interventional

Enrollment

600

Phase

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 Locations

France
- - Angers, France, 49033
    - Recruiting
    - Angers Hospital
    - Contact:
      
      CATALA Laurent, MD
      
      Phone Number: +33 2 41 35 46 35
      
      Email: lacatala@chu-angers.fr
    - Principal Investigator:
      
      CATALA Laurent, MD
  - Clamart, France, 92140
    - Recruiting
    - Antoine Béclère Hospital
    - Contact:
      
      DARRÉ Caroline
      
      Phone Number: +33 1 45 37 45 59
      
      Email: caroline.darre@abc.aphp.fr
    - Principal Investigator:
      
      FERNANDEZ Hervé, PhD, MD
  - Créteil, France, 94000
    - Recruiting
    - Créteil Hospital
    - Contact:
      
      UZAN Catherine, MD
      
      Phone Number: +33 6 03 57 86 35
      
      Email: catherine.uzan1@libertysurf.fr
    - Principal Investigator:
      
      LÉONARD Franck, MD
  - Levallois-Perret, France, 92300
    - Recruiting
    - Franco-Britannique Hospital
    - Contact:
      
      MAIROVITZ Valérie, MD
      
      Phone Number: +33 1 46 39 22 97
      
      Email: vabomai@hotmail.com
    - Principal Investigator:
      
      MAIROVITZ Valérie, MD
  - Lille, France, 59037
    - Recruiting
    - Jeanne de Flandre Hospital
    - Contact:
      
      LUCOT Jean-Philippe, MD
      
      Phone Number: +33 3 20 44 64 37
      
      Email: jplucot@chru-lille.fr
    - Principal Investigator:
      
      LUCOT Jean-Philippe, MD
  - Lyon, France, 69288
    - Recruiting
    - Hotel Dieu
    - Contact:
      
      GOLFIER François, PhD
      
      Phone Number: +33 4 72 41 32 44
      
      Email: francois.golfier@chu-lyon.fr
    - Principal Investigator:
      
      GOLFIER François, PhD
  - Marseille, France, 13005
    - Recruiting
    - Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception
    - Contact:
      
      AGOSTINI Aubert, MD
      
      Phone Number: +33 6 10 56 80 52
      
      Email: aubert.agostini@mail.ap-hm.fr
    - Principal Investigator:
      
      AGOSTINI Aubert, MD
  - Marseille, France, 13326
    - Recruiting
    - Assistance Publique Hôpitaux de Marseille ; Hôpital Nord
    - Contact:
      
      BRETELLE Florence, PhD, MD
      
      Phone Number: +33 4 91 96 46 72
      
      Email: florence.bretelle@mail-ap-hm.fr
    - Principal Investigator:
      
      BRETELLE Florence, PhD, MD
  - Nancy, France, 54042
    - Recruiting
    - Maternité régionale de Nancy
    - Contact:
      
      DEVAL Bruno, PhD, MD
      
      Phone Number: +33 83 34 44 52
      
      Email: b.deval@maternite.chu-nancy.fr
    - Principal Investigator:
      
      ESZTO Marie-Laure, MD
  - Nantes, France, 44093
    - Recruiting
    - Nantes Hospital
    - Contact:
      
      DARNIS Éric, MD
      
      Phone Number: +33 2 40 08 32 24
      
      Email: eric.darnis@chu-nantes.fr
    - Principal Investigator:
      
      DARNIS Éric, MD
  - Paris, France, 75010
    - Recruiting
    - Lariboisière Hospital
    - Contact:
      
      FAZEL Afchine, MD
      
      Phone Number: +33 1 49 95 85 42
      
      Email: afchine.fazel@lrb.aphp.fr
    - Principal Investigator:
      
      FAZEL Afchine, MD
  - Paris, France, 75679
    - Recruiting
    - Cochin Hospital
    - Contact:
      
      LEONARD Franck, MD
      
      Phone Number: +33 1 58 41 18 81
      
      Email: franck.leonard@cch.aphp.fr
    - Principal Investigator:
      
      CHOPIN Nicolas, MD
  - Poissy, France, 78303
    - Recruiting
    - Poissy Saint-Germain-en-Laye Hospital
    - Contact:
      
      BELOT Franck, MD
      
      Phone Number: +33 6 67 28 61 15
      
      Email: af.belot@gmail.com
    - Principal Investigator:
      
      BELOT Franck, MD
  - Roubaix, France, 59100
    - Recruiting
    - Roubaix hospital
    - Contact:
      
      LE GOUEFF Françoise, MD
      
      Phone Number: +33 3 20 99 32 50
      
      Email: francoise.le-goueff@ch-roubaix.fr
    - Principal Investigator:
      
      LE GOUEFF Francoise, MD
  - Rouen, France, 76031
    - Recruiting
    - Charles Nicolle Hospital
    - Contact:
      
      RESCH Benoît, MD
      
      Phone Number: +33 2 32 88 89 90
      
      Email: benoit.resch@chu-rouen.fr
    - Principal Investigator:
      
      RESCH Benoît, MD
  - Schiltigheim, France, 67303
    - Recruiting
    - CMCO
    - Contact:
      
      VAYSSIERE Christophe, MD
      
      Phone Number: +33 3 88 62 83 00
      
      Email: cvayssiere@club-internet.fr
    - Principal Investigator:
      
      THOMA Véronique, MD
  - Tours, France, 37000
    - Not yet recruiting
    - Tours hospital
    - Contact:
      
      MARRET Henri, PhD
      
      Phone Number: +33 2 47 47 82 59
      
      Email: marret@med.univ-tours.fr
    - Principal Investigator:
      
      MARRET Henri, Ph D
  - Versailles, France, 78157
    - Recruiting
    - Versailles Hospital ; Hôpital André Mignot
    - Contact:
      
      PANEL Pierre, MD
      
      Phone Number: +33 1 39 63 97 33
      
      Email: ppanel@ch-versailles.fr
    - 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

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

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

Outcome Measure
Subsequent fertility with 2 years follow-up

Secondary Outcome Measures

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

Hopital Antoine Beclere

Investigators

Study Chair: Fernandez Hervé, PhD MD, Hopital Antoine Beclere

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

General information about Ectopic Pregnancies

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

August 1, 2004

Study Completion

July 1, 2008

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

September 8, 2006

Last Update Submitted That Met QC Criteria

September 7, 2006

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.