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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00137982
Recruitment Status : Unknown
Verified August 2005 by Hopital Antoine Beclere.
Recruitment status was:  Recruiting
First Posted : August 30, 2005
Last Update Posted : September 8, 2006
Information provided by:
Hopital Antoine Beclere

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.

Condition or disease Intervention/treatment Phase
Tubal Pregnancy Procedure: Treatment of ectopic pregnancy Phase 4

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  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2004
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Subsequent fertility with 2 years follow-up

Secondary Outcome Measures :
  1. Complications of treatments
  2. Time of hospitalisation
  3. Decrease curve of beta-hCG after treatment
  4. Success rate in each group

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00137982

Contact: Fernandez Hervé, PhD MD +33 1 45 37 44 69

Angers Hospital Recruiting
Angers, France, 49033
Contact: CATALA Laurent, MD    +33 2 41 35 46 35   
Principal Investigator: CATALA Laurent, MD         
Antoine Beclere Hospital Recruiting
Clamart, France, 92140
Contact: DARRÉ Caroline    +33 1 45 37 45 59   
Principal Investigator: FERNANDEZ Hervé, PhD, MD         
Créteil Hospital Recruiting
Créteil, France, 94000
Contact: UZAN Catherine, MD    +33 6 03 57 86 35   
Principal Investigator: LÉONARD Franck, MD         
Franco-Britannique Hospital Recruiting
Levallois-Perret, France, 92300
Contact: MAIROVITZ Valérie, MD    +33 1 46 39 22 97   
Principal Investigator: MAIROVITZ Valérie, MD         
Jeanne de Flandre Hospital Recruiting
Lille, France, 59037
Contact: LUCOT Jean-Philippe, MD    +33 3 20 44 64 37   
Principal Investigator: LUCOT Jean-Philippe, MD         
Hôtel Dieu Recruiting
Lyon, France, 69288
Contact: GOLFIER François, PhD    +33 4 72 41 32 44   
Principal Investigator: GOLFIER François, PhD         
Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception Recruiting
Marseille, France, 13005
Contact: AGOSTINI Aubert, MD    +33 6 10 56 80 52   
Principal Investigator: AGOSTINI Aubert, MD         
Assistance Publique Hôpitaux de Marseille ; Hôpital Nord Recruiting
Marseille, France, 13326
Contact: BRETELLE Florence, PhD, MD    +33 4 91 96 46 72   
Principal Investigator: BRETELLE Florence, PhD, MD         
Maternité Régionale de Nancy Recruiting
Nancy, France, 54042
Contact: DEVAL Bruno, PhD, MD    +33 83 34 44 52   
Principal Investigator: ESZTO Marie-Laure, MD         
Nantes Hospital Recruiting
Nantes, France, 44093
Contact: DARNIS Éric, MD    +33 2 40 08 32 24   
Principal Investigator: DARNIS Éric, MD         
Lariboisière Hospital Recruiting
Paris, France, 75010
Contact: FAZEL Afchine, MD    +33 1 49 95 85 42   
Principal Investigator: FAZEL Afchine, MD         
Cochin Hospital Recruiting
Paris, France, 75679
Contact: LEONARD Franck, MD    +33 1 58 41 18 81   
Principal Investigator: CHOPIN Nicolas, MD         
Poissy Saint-Germain-en-Laye Hospital Recruiting
Poissy, France, 78303
Contact: BELOT Franck, MD    +33 6 67 28 61 15   
Principal Investigator: BELOT Franck, MD         
Roubaix Hospital Recruiting
Roubaix, France, 59100
Contact: LE GOUEFF Françoise, MD    +33 3 20 99 32 50   
Principal Investigator: LE GOUEFF Francoise, MD         
Charles Nicolle Hospital Recruiting
Rouen, France, 76031
Contact: RESCH Benoît, MD    +33 2 32 88 89 90   
Principal Investigator: RESCH Benoît, MD         
CMCO Recruiting
Schiltigheim, France, 67303
Contact: VAYSSIERE Christophe, MD    +33 3 88 62 83 00   
Principal Investigator: THOMA Véronique, MD         
Tours Hospital Not yet recruiting
Tours, France, 37000
Contact: MARRET Henri, PhD    +33 2 47 47 82 59   
Principal Investigator: MARRET Henri, Ph D         
Versailles Hospital ; Hôpital André Mignot Recruiting
Versailles, France, 78157
Contact: PANEL Pierre, MD    +33 1 39 63 97 33   
Principal Investigator: RAYNAL Pierre, MD         
Sponsors and Collaborators
Hopital Antoine Beclere
Study Chair: Fernandez Hervé, PhD MD Hopital Antoine Beclere