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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137982
Recruitment Status : Unknown
Verified August 2005 by Hopital Antoine Beclere.
Recruitment status was:  Recruiting
First Posted : August 30, 2005
Last Update Posted : September 8, 2006
Sponsor:
Information provided by:
Hopital Antoine Beclere

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.

Condition or disease Intervention/treatment Phase
Tubal Pregnancy Procedure: Treatment of ectopic pregnancy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2004
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Subsequent fertility with 2 years follow-up

Secondary Outcome Measures :
  1. Complications of treatments
  2. Time of hospitalisation
  3. Decrease curve of beta-hCG after treatment
  4. Success rate in each group


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137982


Contacts
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Contact: Fernandez Hervé, PhD MD +33 1 45 37 44 69 herve.fernandez@abc.aphp.fr

Locations
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Sponsors and Collaborators
Hopital Antoine Beclere
Investigators
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Study Chair: Fernandez Hervé, PhD MD Hopital Antoine Beclere
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00137982    
Other Study ID Numbers: P030409/AOR03040
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: August 2005
Keywords provided by Hopital Antoine Beclere:
Ectopic pregnancy
Surgical treatment
Medical treatment
Fertility
Additional relevant MeSH terms:
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Pregnancy, Tubal
Pregnancy, Ectopic
Pregnancy Complications