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

NCT00137982 — Phase 4, Unknown, 600 participants, Hopital Antoine Beclere
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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

RegistryNCT00137982
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment600
SponsorHopital Antoine Beclere (Other)
ConditionsTubal Pregnancy
InterventionsTreatment of ectopic pregnancy (Procedure)
Datesstart 2004-08-01, completion 2008-07-01, first posted 2005-08-30, last updated 2006-09-08
Locations18 sites in France

Related Papers Related Patents Related Grants Related Experts
All trials for Tubal Pregnancy All trials of Treatment of ectopic pregnancy

-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.

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+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.

+Arms and interventions

  • Treatment of ectopic pregnancy (Procedure)

+Outcome measures

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

+Eligibility

Sex: Female, ages: 18 Years to 44 Years

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)

+Locations (18)

FacilityCityCountryStatus
Angers HospitalAngersFranceRecruiting
Antoine Beclere HospitalClamartFranceRecruiting
Créteil HospitalCréteilFranceRecruiting
Franco-Britannique HospitalLevallois-PerretFranceRecruiting
Jeanne de Flandre HospitalLilleFranceRecruiting
Hôtel DieuLyonFranceRecruiting
Assistance Publique Hôpitaux de Marseille ; Maternité de la ConceptionMarseilleFranceRecruiting
Assistance Publique Hôpitaux de Marseille ; Hôpital NordMarseilleFranceRecruiting
Maternité Régionale de NancyNancyFranceRecruiting
Nantes HospitalNantesFranceRecruiting
Lariboisière HospitalParisFranceRecruiting
Cochin HospitalParisFranceRecruiting
Poissy Saint-Germain-en-Laye HospitalPoissyFranceRecruiting
Roubaix HospitalRoubaixFranceRecruiting
Charles Nicolle HospitalRouenFranceRecruiting
CMCOSchiltigheimFranceRecruiting
Tours HospitalToursFranceNot yet recruiting
Versailles Hospital ; Hôpital André MignotVersaillesFranceRecruiting

+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. doi: 10.1093/humupd/dmh043. Epub 2004 Sep 23. PMID 15388673
  • Results publication: 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 30520964
  • Results publication: 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 23482340

+Investigators

  • Fernandez Hervé, PhD MD, Study chair, Hopital Antoine Beclere