Clinical trial NCT00137982: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tubal Pregnancy
Keywords: Ectopic pregnancy
Surgical treatment
Medical treatment
Fertility
Lead sponsor: Hopital Antoine Beclere
Sponsor class: OTHER
First posted: 2005-08-30
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Subsequent fertility with 2 years follow-up
Secondary outcomes:
measure: Complications of treatments
measure: Time of hospitalisation
measure: Decrease curve of beta-hCG after treatment
measure: Success rate in each group
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers Hospital
city: Clamart
country: France
facility: Antoine Beclere Hospital
city: Créteil
country: France
facility: Créteil Hospital
city: Levallois-Perret
country: France
facility: Franco-Britannique Hospital
city: Lille
country: France
facility: Jeanne de Flandre Hospital
city: Lyon
country: France
facility: Hôtel Dieu
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille ; Maternité de la Conception
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille ; Hôpital Nord
city: Nancy
country: France
facility: Maternité Régionale de Nancy
city: Nantes
country: France
facility: Nantes Hospital
city: Paris
country: France
facility: Lariboisière Hospital
city: Paris
country: France
facility: Cochin Hospital
city: Poissy
country: France
facility: Poissy Saint-Germain-en-Laye Hospital
city: Roubaix
country: France
facility: Roubaix Hospital
city: Rouen
country: France
facility: Charles Nicolle Hospital
city: Schiltigheim
country: France
facility: CMCO
city: Tours
country: France
facility: Tours Hospital
city: Versailles
country: France
facility: Versailles Hospital ; Hôpital André Mignot
Study officials:
affiliation: Hopital Antoine Beclere
name: Fernandez Hervé, PhD MD
role: STUDY_CHAIR
References:
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.
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.
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.