Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility - Full Text View

Sponsored by:	Hopital Antoine Beclere
Information provided by:	Hopital Antoine Beclere
ClinicalTrials.gov Identifier:	NCT00137982

Purpose

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	Intervention	Phase
Tubal Pregnancy	Procedure: Treatment of ectopic pregnancy	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Infertility Surgery

U.S. FDA Resources

Further study details as provided by Hopital Antoine Beclere:

Primary Outcome Measures:

Subsequent fertility with 2 years follow-up

Secondary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	August 2004
Estimated Study Completion Date:	July 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 44 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137982

Contacts

Contact: Fernandez Hervé, PhD MD

+33 1 45 37 44 69

herve.fernandez@abc.aphp.fr

Locations

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

Sponsors and Collaborators

Hopital Antoine Beclere

Investigators

Study Chair:

Fernandez Hervé, PhD MD

Hopital Antoine Beclere

More Information

Additional Information:

General information about Ectopic Pregnancies This link exits the ClinicalTrials.gov site

Publications:

Fernandez H, Gervaise A. Ectopic pregnancies after infertility treatment: modern diagnosis and therapeutic strategy. Hum Reprod Update. 2004 Nov-Dec;10(6):503-13. Epub 2004 Sep 23. Review.

Study ID Numbers:	P030409/AOR03040
Study First Received:	August 29, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00137982 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hopital Antoine Beclere:

Ectopic pregnancy
Surgical treatment
Medical treatment
Fertility

Study placed in the following topic categories:

Infertility
Pregnancy Complications
Pregnancy, Ectopic
Ectopic Pregnancy

Methotrexate
Pregnancy, Tubal
Cardiac Complexes, Premature

Additional relevant MeSH terms:

Pregnancy Complications
Pregnancy, Ectopic
Pregnancy, Tubal

ClinicalTrials.gov processed this record on September 11, 2009