NCT00137982

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_4

Geographic Reach
1 country

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 8, 2006

Status Verified

August 1, 2005

First QC Date

August 29, 2005

Last Update Submit

September 7, 2006

Conditions

Tubal Pregnancy

Keywords

Ectopic pregnancySurgical treatmentMedical treatmentFertility

Outcome Measures

Primary Outcomes (1)

  • Subsequent fertility with 2 years follow-up

Secondary Outcomes (4)

  • Complications of treatments

  • Time of hospitalisation

  • Decrease curve of beta-hCG after treatment

  • Success rate in each group

Interventions

Treatment of ectopic pregnancyPROCEDURE

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis by ultra sound of ectopic pregnancy (EP)
  • Patients aged \> 18 years old
  • Desire of future pregnancy

You may not qualify if:

  • EP by failure of contraception
  • EP associated with in vitro fertilization (IVF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Angers Hospital

Angers, 49033, France

RECRUITING

Antoine Beclere Hospital

Clamart, 92140, France

RECRUITING

Créteil Hospital

Créteil, 94000, France

RECRUITING

Franco-Britannique Hospital

Levallois-Perret, 92300, France

RECRUITING

Jeanne de Flandre Hospital

Lille, 59037, France

RECRUITING

Hôtel Dieu

Lyon, 69288, France

RECRUITING

Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception

Marseille, 13005, France

RECRUITING

Assistance Publique Hôpitaux de Marseille ; Hôpital Nord

Marseille, 13326, France

RECRUITING

Maternité Régionale de Nancy

Nancy, 54042, France

RECRUITING

Nantes Hospital

Nantes, 44093, France

RECRUITING

Lariboisière Hospital

Paris, 75010, France

RECRUITING

Cochin Hospital

Paris, 75679, France

RECRUITING

Poissy Saint-Germain-en-Laye Hospital

Poissy, 78303, France

RECRUITING

Roubaix Hospital

Roubaix, 59100, France

RECRUITING

Charles Nicolle Hospital

Rouen, 76031, France

RECRUITING

CMCO

Schiltigheim, 67303, France

RECRUITING

Tours Hospital

Tours, 37000, France

NOT YET RECRUITING

Versailles Hospital ; Hôpital André Mignot

Versailles, 78157, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15388673BACKGROUND

  • 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.

    PMID: 30520964DERIVED

  • 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.

    PMID: 23482340DERIVED

MeSH Terms

Conditions

Pregnancy, TubalPregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Fernandez Hervé, PhD MD

    Hopital Antoine Beclere

    STUDY CHAIR

Central Study Contacts

Fernandez Hervé, PhD MD

CONTACT

+33 1 45 37 44 69herve.fernandez@abc.aphp.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

August 1, 2004

Study Completion

July 1, 2008

Last Updated

September 8, 2006

Record last verified: 2005-08

Locations

FR(18)