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Clinical Trial: Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility.
This study is currently recruiting patients.
Verified by Hopital Antoine Beclere August 2005
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Purpose
Three protocols are used to treat ectopic pregnancies : medical treatment by Methotrexate, conservative or radical surgery. There are no data about the subsequent fertility except in cohort study. We 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 |
MedlinePlus related topics: Pregnancy Loss
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.
Further Study Details:
Primary Outcomes: Subsequent fertility with 2 years follow-up
Secondary Outcomes: Complications of treatments; Time of hospitalisation; Decrease curve of beta-hCG after treatment; Success rate in each group
Expected Total Enrollment: 600
Secondary Outcomes: Complications of treatments; Time of hospitalisation; Decrease curve of beta-hCG after treatment; Success rate in each group
Expected Total Enrollment: 600
Study start: August 2004; Expected completion: June 2009
Last follow-up: July 2008; Data entry closure: December 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 follow-up during 2 years with phone contact every 6 months.
Eligibility
Ages Eligible for Study: 18 Years - 44 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
- Diagnostic 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 Fecondation (IVF)
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00137982
Fernandez Hervé, PhD MD +33 1 45 37 44 69 herve.fernandez@abc.aphp.fr
France
Antoine Beclere Hospital, Clamart, 92140, France; Recruiting
DARRÉ Caroline +33 1 45 37 45 59 caroline.darre@abc.aphp.fr
FERNANDEZ Hervé, PhD, Principal Investigator
FERNANDEZ Hervé, PhD, Principal Investigator
Jeanne de Flandre Hospital, Lille, 59037, France; Recruiting
LUCOT Jean-Philippe, MD +33 3 20 44 64 37 jplucot@chru-lille.fr
LUCOT Jean-Philippe, MD, Principal Investigator
LUCOT Jean-Philippe, MD, Principal Investigator
Poissy Saint-Germain-en-Laye Hospital, Poissy, 78303, France; Recruiting
FAUCONNIER Arnaud, MD +33 6 71 65 69 93 afauconnier@chi-poissy-st-germain.fr
FAUCONNIER Arnaud, MD, Principal Investigator
FAUCONNIER Arnaud, MD, Principal Investigator
Angers Hospital, Angers, 49033, France; Recruiting
CATALA Laurent, MD +33 2 41 35 46 35 lacatala@chu-angers.fr
CATALA Laurent, MD, Principal Investigator
CATALA Laurent, MD, Principal Investigator
CMCO, Schiltigheim, 67303, France; Recruiting
SEBAHOUN Valérie, MD +33 3 88 62 83 00 Sebahoun.valerie@wanadoo.fr
SEBAHOUN Valerie, MD, Principal Investigator
SEBAHOUN Valerie, MD, Principal Investigator
Charles Nicolle Hospital, Rouen, 76031, France; Recruiting
RESCH Benoît, MD +33 2 32 88 89 90 benoit.resch@chu-rouen.fr
RESCH Benoît, MD, Principal Investigator
RESCH Benoît, MD, Principal Investigator
Franco-Britannique Hospital, Levallois-Perret, 92300, France; Recruiting
MAIROVITZ Valérie, MD +33 1 46 39 22 97 vabomai@hotmail.com
MAIROVITZ Valérie, MD, Principal Investigator
MAIROVITZ Valérie, MD, Principal Investigator
Hôtel Dieu, Lyon, 69288, France; Recruiting
GOLFIER François, PhD +33 4 72 41 32 44 francois.golfier@chu-lyon.fr
GOLFIER François, PhD, Principal Investigator
GOLFIER François, PhD, Principal Investigator
Tours Hospital, Tours, 37000, France; Not yet recruiting
BODY Gilles, PhD +33 2 47 47 47 42 body@med.univ-tours.fr
BODY Gilles, Ph D, Principal Investigator
BODY Gilles, Ph D, Principal Investigator
Lariboisière Hospital, Paris, 75010, France; Recruiting
FAZEL Afchine, MD +33 1 49 95 85 42 afchine.fazel@lrb.aphp.fr
FAZEL Afchine, MD, Principal Investigator
FAZEL Afchine, MD, Principal Investigator
Créteil Hospital, Créteil, 94000, France; Recruiting
LÉONARD Franck, MD +33 1 45 17 55 44 Franck.leonard@chicreteil.fr
LÉONARD Franck, MD, Principal Investigator
LÉONARD Franck, MD, Principal Investigator
Cochin Hospital, Paris, 75679, France; Recruiting
CHOPIN Nicolas, MD +33 1 58 41 18 81 nicolas.chopin@cch.aphp.fr
CHOPIN Nicolas, MD, Principal Investigator
CHOPIN Nicolas, MD, Principal Investigator
Nantes Hospital, Nantes, 44093, France; Not yet recruiting
DARNIS Éric, MD +33 2 40 08 32 24 eric.darnis@chu-nantes.fr
DARNIS Éric, MD, Principal Investigator
DARNIS Éric, MD, Principal Investigator
Roubaix Hospital, Roubaix, 59100, France; Not yet recruiting
Study chairs or principal investigators
Fernandez Hervé, PhD MD, Study Chair, Hopital Antoine Beclere
More Information
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
Last Updated: August 29, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00137982
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 29, 2005
Record first received: August 29, 2005
ClinicalTrials.gov Identifier: NCT00137982
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-30
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