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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014