Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Hopital Antoine Beclere.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hopital Antoine Beclere
Information provided by:
Hopital Antoine Beclere
ClinicalTrials.gov Identifier:
NCT00137982
First received: August 29, 2005
Last updated: September 7, 2006
Last verified: August 2005
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
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 |
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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| CMCO | Recruiting |
| Schiltigheim, France, 67303 | |
| Contact: VAYSSIERE Christophe, MD +33 3 88 62 83 00 cvayssiere@club-internet.fr | |
| Principal Investigator: THOMA Véronique, MD | |
| 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 | |
| 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 | |
Sponsors and Collaborators
Hopital Antoine Beclere
Investigators
| Study Chair: | Fernandez Hervé, PhD MD | Hopital Antoine Beclere |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00137982 History of Changes |
| Other Study ID Numbers: | P030409/AOR03040 |
| Study First Received: | August 29, 2005 |
| Last Updated: | September 7, 2006 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hopital Antoine Beclere:
|
Ectopic pregnancy Surgical treatment Medical treatment Fertility |
Additional relevant MeSH terms:
|
Pregnancy, Ectopic Pregnancy, Tubal Pregnancy Complications |
ClinicalTrials.gov processed this record on June 17, 2013