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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
  Purpose

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.


Condition Intervention Phase
Infertility
Endometriosis Stage I and II
 Drug: Zoladex
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AZ Jan Palfijn Gent:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zoladex
After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
 Drug: Zoladex
after surgical vaporization patients are treated with Zoladex for 3 months
No Intervention: vaporization only
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682642

Contacts
Contact: Wim Decleer, gynecologist 0032 9 3259220 wim.decleer@janpalfijngent.be
Contact: Paul Devroey, professor 0032 9 2248070 ivf.studie@janpalfijngent.be

Locations
Belgium
AZ Jan Palfijn Recruiting
Gent, Oost-vlaanderen, Belgium, 9000
Contact: Wim Decleer, gynecologist     0032 9 2243024     wim.decleer@janpalfijngent.be    
Contact     0032 9 2248850     ivf.centrum@janpalfijngent.be    
Principal Investigator: Wim Decleer, gynecologist            
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
Investigators
Principal Investigator: Wim Decleer, gynecologist IVF Centrum Jan Palfijn Gent
  More Information

No publications provided

Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01682642     History of Changes
Other Study ID Numbers: 2012-000784-25
Study First Received: August 23, 2012
Last Updated: September 7, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by AZ Jan Palfijn Gent:
endometriosis
pregnancy
IVF/ICSI

Additional relevant MeSH terms:
Endometriosis
Infertility
Genital Diseases, Female
Genital Diseases, Male
Goserelin
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013