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The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.

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ClinicalTrials.gov Identifier: NCT01682642
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : March 20, 2015
Last Update Posted : March 20, 2015
Sponsor:
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent

Study Description
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Brief Summary:
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 In Vitro Fertilization (IVF) treatment.

Condition or disease Intervention/treatment Phase
Infertility Endometriosis Drug: Zoladex Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IVF Outcome in Patients With Peritoneal Endometriosis. The Impact of a Hormonal Treatment of the Endometriosis Prior to the IVF on the Pregnancy Rates.
Study Start Date : March 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arms and Interventions
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Arm Intervention/treatment
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 before starting IVF treatment
No Intervention: vaporization only
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Metaphase II Cells (MII) [ Time Frame: 3 weeks ]
    number of MII cells retrieved


Secondary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 12 weeks ]
    The number of ongoing pregnancies obtained which still is the most important issue for the patients.

  2. Good Embryo Quality [ Time Frame: 3 days after oocyte retrieval ]
    The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.

  3. Number of Pro Nuclear Cell (2PN) [ Time Frame: 1 day after oocyte retrieval ]
    number of 2PN

  4. Number of Cryopreserved Embryos [ Time Frame: 1 week after oocyte retrieval ]
    number of blastocytes that can be cryopreserved

  5. Total Follicle Stimulating Hormone (FSH) Dose [ Time Frame: 3 weeks ]
    total dose of FSH needed at the end of stimulation


Other Outcome Measures:
  1. Number of Days of Stimulation [ Time Frame: 3 weeks ]
    number of days needed before follicles in the ovary are mature for oocyte retrieval


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • laparoscopical vaporization of endometriosis
  • 1,2, 3e IVF cycle
  • endometriosis stage I and II
  • younger than 38 years

Exclusion Criteria:

  • endometriosis cysts
  • uterine pathology
  • endocrinological diseases and problems
Contacts and Locations
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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): NCT01682642


Locations
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Belgium
AZ Jan Palfijn
Gent, Oost-vlaanderen, Belgium, 9000
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
Investigators
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Principal Investigator: Wim Decleer, gynecologist Fertility Center AZ Jan Palfijn Gent
Study Chair: Paul Devroey, Professor Fertility Center AZ Jan Palfijn Gent
More Information
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Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01682642    
Other Study ID Numbers: 2012-000784-25
First Posted: September 11, 2012    Key Record Dates
Results First Posted: March 20, 2015
Last Update Posted: March 20, 2015
Last Verified: March 2015
Keywords provided by Dr. Decleer Wim, AZ Jan Palfijn Gent:
endometriosis
pregnancy
In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI)
peritoneal implants
embryo quality
Additional relevant MeSH terms:
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Infertility
Endometriosis
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents