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

NCT ID: NCT00137982

Last Updated: 2006-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Tubal Pregnancy

Keywords

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Ectopic pregnancy Surgical treatment Medical treatment Fertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Treatment of ectopic pregnancy

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Antoine Beclere

OTHER

Sponsor Role lead

Principal Investigators

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Fernandez Hervé, PhD MD

Role: STUDY_CHAIR

Hopital Antoine Beclere

Locations

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Angers Hospital

Angers, , France

Site Status RECRUITING

Antoine Beclere Hospital

Clamart, , France

Site Status RECRUITING

Créteil Hospital

Créteil, , France

Site Status RECRUITING

Franco-Britannique Hospital

Levallois-Perret, , France

Site Status RECRUITING

Jeanne de Flandre Hospital

Lille, , France

Site Status RECRUITING

Hôtel Dieu

Lyon, , France

Site Status RECRUITING

Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception

Marseille, , France

Site Status RECRUITING

Assistance Publique Hôpitaux de Marseille ; Hôpital Nord

Marseille, , France

Site Status RECRUITING

Maternité Régionale de Nancy

Nancy, , France

Site Status RECRUITING

Nantes Hospital

Nantes, , France

Site Status RECRUITING

Lariboisière Hospital

Paris, , France

Site Status RECRUITING

Cochin Hospital

Paris, , France

Site Status RECRUITING

Poissy Saint-Germain-en-Laye Hospital

Poissy, , France

Site Status RECRUITING

Roubaix Hospital

Roubaix, , France

Site Status RECRUITING

Charles Nicolle Hospital

Rouen, , France

Site Status RECRUITING

CMCO

Schiltigheim, , France

Site Status RECRUITING

Tours Hospital

Tours, , France

Site Status NOT_YET_RECRUITING

Versailles Hospital ; Hôpital André Mignot

Versailles, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Fernandez Hervé, PhD MD

Role: CONTACT

Phone: +33 1 45 37 44 69

Email: [email protected]

Facility Contacts

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CATALA Laurent, MD

Role: primary

DARRÉ Caroline

Role: primary

UZAN Catherine, MD

Role: primary

MAIROVITZ Valérie, MD

Role: primary

LUCOT Jean-Philippe, MD

Role: primary

GOLFIER François, PhD

Role: primary

AGOSTINI Aubert, MD

Role: primary

BRETELLE Florence, PhD, MD

Role: primary

DEVAL Bruno, PhD, MD

Role: primary

DARNIS Éric, MD

Role: primary

FAZEL Afchine, MD

Role: primary

LEONARD Franck, MD

Role: primary

BELOT Franck, MD

Role: primary

LE GOUEFF Françoise, MD

Role: primary

RESCH Benoît, MD

Role: primary

VAYSSIERE Christophe, MD

Role: primary

MARRET Henri, PhD

Role: primary

PANEL Pierre, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15388673 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30520964 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23482340 (View on PubMed)

Other Identifiers

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P030409/AOR03040

Identifier Type: -

Identifier Source: org_study_id