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Pregnancy Outcome After IVF/ICSI in Endometriosis Patients Stage I and II

This study is currently recruiting participants.
Verified September 2012 by AZ Jan Palfijn Gent
Sponsor:
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier:
NCT01682642
First received: August 23, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes

August 23, 2012
September 7, 2012
March 2012
September 2013   (final data collection date for primary outcome measure)
  • 2 PN fertilization [ Time Frame: 24 hours after ICSI ] [ Designated as safety issue: No ]
    laboratory follow up of the fertilized egg during the first 24h
  • embryo quality [ Time Frame: 3 to 5 days after egg retrieval ] [ Designated as safety issue: No ]
    The development of the embryo during the first 3 to 5 days after fertilization.
Same as current
Complete list of historical versions of study NCT01682642 on ClinicalTrials.gov Archive Site
pregnancy rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The number of ongoing pregnancies obtained wich still is the most important issue for the patients.
Same as current
Not Provided
Not Provided
 
Pregnancy Outcome After IVF/ICSI in Endometriosis Patients Stage I and II
Pregnancy Outcome After IVF/ICSI in Endometriosis Associated Tubal Factor Infertility in Endometriosis Stage I and II. Comparison of Results of IVF After Surgical Therapy Only or After Surgical Vaporisation Associated With Medical Therapy. A Prospective Randomized Study.

In this study of endometriosis patients we compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex)with patients receiving only surgical therapy. In both cases they immediately start IVF treatment.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infertility
  • Endometriosis Stage I and II
Drug: Zoladex
after surgical vaporization patients are treated with Zoladex for 3 months
  • Active Comparator: Zoladex
    After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
    Intervention: Drug: Zoladex
  • No Intervention: vaporization only
    Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1,2, 3e IVF cycle
  • endometriosis stage I and II
  • <38 years old

Exclusion Criteria:

  • endometriosis cysts
  • uterine pathology
  • endocrinological diseases and problems
Female
18 Years to 38 Years
No
Contact: Wim Decleer, gynecologist 0032 9 3259220 wim.decleer@janpalfijngent.be
Contact: Paul Devroey, professor 0032 9 2248070 ivf.studie@janpalfijngent.be
Belgium
 
NCT01682642
2012-000784-25
Yes
Dr. Decleer Wim, AZ Jan Palfijn Gent
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
Principal Investigator: Wim Decleer, gynecologist IVF Centrum Jan Palfijn Gent
AZ Jan Palfijn Gent
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP