Back to resultsEvaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility
Primary Purpose
Tubal Pregnancy
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Treatment of ectopic pregnancy
Sponsored by
About this trial
This is an interventional treatment trial for Tubal Pregnancy focused on measuring Ectopic pregnancy, Surgical treatment, Medical treatment, Fertility
Eligibility 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)
Sites / Locations
- Angers HospitalRecruiting
- Antoine Beclere HospitalRecruiting
- Créteil HospitalRecruiting
- Franco-Britannique HospitalRecruiting
- Jeanne de Flandre HospitalRecruiting
- Hôtel DieuRecruiting
- Assistance Publique Hôpitaux de Marseille ; Maternité de la ConceptionRecruiting
- Assistance Publique Hôpitaux de Marseille ; Hôpital NordRecruiting
- Maternité Régionale de NancyRecruiting
- Nantes HospitalRecruiting
- Lariboisière HospitalRecruiting
- Cochin HospitalRecruiting
- Poissy Saint-Germain-en-Laye HospitalRecruiting
- Roubaix HospitalRecruiting
- Charles Nicolle HospitalRecruiting
- CMCORecruiting
- Tours Hospital
- Versailles Hospital ; Hôpital André MignotRecruiting
Outcomes
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
Full Information
NCT ID
NCT00137982
First Posted
August 29, 2005
Last Updated
September 7, 2006
Sponsor
Hopital Antoine Beclere
1. Study Identification
Unique Protocol Identification Number
NCT00137982
Brief Title
Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility
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 Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hopital Antoine Beclere
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tubal Pregnancy
Keywords
Ectopic pregnancy, Surgical treatment, Medical treatment, Fertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Treatment of ectopic pregnancy
Primary Outcome Measure Information:
Title
Subsequent fertility with 2 years follow-up
Secondary Outcome Measure Information:
Title
Complications of treatments
Title
Time of hospitalisation
Title
Decrease curve of beta-hCG after treatment
Title
Success rate in each group
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernandez Hervé, PhD MD
Phone
+33 1 45 37 44 69
Email
herve.fernandez@abc.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernandez Hervé, PhD MD
Organizational Affiliation
Hopital Antoine Beclere
Official's Role
Study Chair
Facility Information:
Facility Name
Angers Hospital
City
Angers
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CATALA Laurent, MD
Phone
+33 2 41 35 46 35
Email
lacatala@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
CATALA Laurent, MD
Facility Name
Antoine Beclere Hospital
City
Clamart
ZIP/Postal Code
92140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DARRÉ Caroline
Phone
+33 1 45 37 45 59
Email
caroline.darre@abc.aphp.fr
First Name & Middle Initial & Last Name & Degree
FERNANDEZ Hervé, PhD, MD
Facility Name
Créteil Hospital
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UZAN Catherine, MD
Phone
+33 6 03 57 86 35
Email
catherine.uzan1@libertysurf.fr
First Name & Middle Initial & Last Name & Degree
LÉONARD Franck, MD
Facility Name
Franco-Britannique Hospital
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MAIROVITZ Valérie, MD
Phone
+33 1 46 39 22 97
Email
vabomai@hotmail.com
First Name & Middle Initial & Last Name & Degree
MAIROVITZ Valérie, MD
Facility Name
Jeanne de Flandre Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LUCOT Jean-Philippe, MD
Phone
+33 3 20 44 64 37
Email
jplucot@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
LUCOT Jean-Philippe, MD
Facility Name
Hôtel Dieu
City
Lyon
ZIP/Postal Code
69288
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GOLFIER François, PhD
Phone
+33 4 72 41 32 44
Email
francois.golfier@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
GOLFIER François, PhD
Facility Name
Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AGOSTINI Aubert, MD
Phone
+33 6 10 56 80 52
Email
aubert.agostini@mail.ap-hm.fr
First Name & Middle Initial & Last Name & Degree
AGOSTINI Aubert, MD
Facility Name
Assistance Publique Hôpitaux de Marseille ; Hôpital Nord
City
Marseille
ZIP/Postal Code
13326
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BRETELLE Florence, PhD, MD
Phone
+33 4 91 96 46 72
Email
florence.bretelle@mail-ap-hm.fr
First Name & Middle Initial & Last Name & Degree
BRETELLE Florence, PhD, MD
Facility Name
Maternité Régionale de Nancy
City
Nancy
ZIP/Postal Code
54042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DEVAL Bruno, PhD, MD
Phone
+33 83 34 44 52
Email
b.deval@maternite.chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
ESZTO Marie-Laure, MD
Facility Name
Nantes Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DARNIS Éric, MD
Phone
+33 2 40 08 32 24
Email
eric.darnis@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
DARNIS Éric, MD
Facility Name
Lariboisière Hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FAZEL Afchine, MD
Phone
+33 1 49 95 85 42
Email
afchine.fazel@lrb.aphp.fr
First Name & Middle Initial & Last Name & Degree
FAZEL Afchine, MD
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75679
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEONARD Franck, MD
Phone
+33 1 58 41 18 81
Email
franck.leonard@cch.aphp.fr
First Name & Middle Initial & Last Name & Degree
CHOPIN Nicolas, MD
Facility Name
Poissy Saint-Germain-en-Laye Hospital
City
Poissy
ZIP/Postal Code
78303
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BELOT Franck, MD
Phone
+33 6 67 28 61 15
Email
af.belot@gmail.com
First Name & Middle Initial & Last Name & Degree
BELOT Franck, MD
Facility Name
Roubaix Hospital
City
Roubaix
ZIP/Postal Code
59100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LE GOUEFF Françoise, MD
Phone
+33 3 20 99 32 50
Email
francoise.le-goueff@ch-roubaix.fr
First Name & Middle Initial & Last Name & Degree
LE GOUEFF Francoise, MD
Facility Name
Charles Nicolle Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RESCH Benoît, MD
Phone
+33 2 32 88 89 90
Email
benoit.resch@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
RESCH Benoît, MD
Facility Name
CMCO
City
Schiltigheim
ZIP/Postal Code
67303
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VAYSSIERE Christophe, MD
Phone
+33 3 88 62 83 00
Email
cvayssiere@club-internet.fr
First Name & Middle Initial & Last Name & Degree
THOMA Véronique, MD
Facility Name
Tours Hospital
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARRET Henri, PhD
Phone
+33 2 47 47 82 59
Email
marret@med.univ-tours.fr
First Name & Middle Initial & Last Name & Degree
MARRET Henri, Ph D
Facility Name
Versailles Hospital ; Hôpital André Mignot
City
Versailles
ZIP/Postal Code
78157
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PANEL Pierre, MD
Phone
+33 1 39 63 97 33
Email
ppanel@ch-versailles.fr
First Name & Middle Initial & Last Name & Degree
RAYNAL Pierre, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15388673
Citation
Fernandez H, Gervaise A. Ectopic pregnancies after infertility treatment: modern diagnosis and therapeutic strategy. Hum Reprod Update. 2004 Nov-Dec;10(6):503-13. doi: 10.1093/humupd/dmh043. Epub 2004 Sep 23.
Results Reference
background
PubMed Identifier
30520964
Citation
Bourel G, Pelletier-Fleury N, Bouyer J, Delbarre A, Fernandez H, Capmas P. Cost-effectiveness analysis of medical management versus conservative surgery for early tubal pregnancy. Hum Reprod. 2019 Feb 1;34(2):261-267. doi: 10.1093/humrep/dey352.
Results Reference
derived
PubMed Identifier
23482340
Citation
Fernandez H, Capmas P, Lucot JP, Resch B, Panel P, Bouyer J; GROG. Fertility after ectopic pregnancy: the DEMETER randomized trial. Hum Reprod. 2013 May;28(5):1247-53. doi: 10.1093/humrep/det037. Epub 2013 Mar 12.
Results Reference
derived
Learn more about this trial
Evaluation of Therapeutic Strategies for Treatment of Ectopic Pregnancies (EP) and Evaluation of Subsequent Fertility
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