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

Tubal Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00137982
• Other study ID #: P030409/AOR03040
• Status: Recruiting
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: September 7, 2006
• Start date: August 2004
• Est. completion date: July 2008

Study information

• Verified date: August 2005
• Source: Hopital Antoine Beclere
• Contact: Fernandez Hervé, PhD MD
• Phone: +33 1 45 37 44 69
• Email: herve.fernandez[@]abc.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy, Ectopic
• Tubal Pregnancy

Intervention

Procedure:
• Treatment of ectopic pregnancy

Locations

Country	Name	City	State
France	Angers Hospital	Angers
France	Antoine Beclere Hospital	Clamart
France	Créteil Hospital	Créteil
France	Franco-Britannique Hospital	Levallois-Perret
France	Jeanne de Flandre Hospital	Lille
France	Hôtel Dieu	Lyon
France	Assistance Publique Hôpitaux de Marseille ; Hôpital Nord	Marseille
France	Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception	Marseille
France	Maternité Régionale de Nancy	Nancy
France	Nantes Hospital	Nantes
France	Cochin Hospital	Paris
France	Lariboisière Hospital	Paris
France	Poissy Saint-Germain-en-Laye Hospital	Poissy
France	Roubaix Hospital	Roubaix
France	Charles Nicolle Hospital	Rouen
France	CMCO	Schiltigheim
France	Tours Hospital	Tours
France	Versailles Hospital ; Hôpital André Mignot	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Antoine Beclere

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subsequent fertility with 2 years follow-up
Secondary	Complications of treatments
Secondary	Time of hospitalisation
Secondary	Decrease curve of beta-hCG after treatment
Secondary	Success rate in each group

External Links

•   General information about Ectopic Pregnancies