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

This study has been completed.
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: March 9, 2015
Last verified: March 2015

August 23, 2012
March 9, 2015
March 2012
October 2014   (final data collection date for primary outcome measure)
Number of Metaphase II Cells (MII) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
number of MII cells retrieved
  • 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.
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 which still is the most important issue for the patients.
  • Good Embryo Quality [ Time Frame: 3 days after oocyte retrieval ] [ Designated as safety issue: No ]
    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.
  • Number of Pro Nuclear Cell (2PN) [ Time Frame: 1 day after oocyte retrieval ] [ Designated as safety issue: No ]
    number of 2PN
  • Number of Cryopreserved Embryos [ Time Frame: 1 week after oocyte retrieval ] [ Designated as safety issue: No ]
    number of blastocytes that can be cryopreserved
  • Total Follicle Stimulating Hormone (FSH) Dose [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    total dose of FSH needed at the end of stimulation
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.
Number of Days of Stimulation [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
number of days needed before follicles in the ovary are mature for oocyte retrieval
Not Provided
 
The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
IVF Outcome in Patients With Peritoneal Endometriosis. The Impact of a Hormonal Treatment of the Endometriosis Prior to the IVF on the Pregnancy Rates.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infertility
  • Endometriosis
Drug: Zoladex
after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment
  • 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.
 
Completed
120
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 38 Years
No
Contact information is only displayed when the study is recruiting subjects
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 Fertility Center AZ Jan Palfijn Gent
Study Chair: Paul Devroey, Professor Fertility Center AZ Jan Palfijn Gent
AZ Jan Palfijn Gent
March 2015

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