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
Results First Received: February 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Infertility
Endometriosis
Intervention: Drug: Zoladex

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zoladex After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment.
Vaporization Only After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment).

Participant Flow:   Overall Study
    Zoladex     Vaporization Only  
STARTED     61     59  
COMPLETED     61     58  
NOT COMPLETED     0     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
women between 18 and 38 years

Reporting Groups
  Description
Zoladex

After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.

Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment

Vaporization Only Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Total Total of all reporting groups

Baseline Measures
    Zoladex     Vaporization Only     Total  
Number of Participants  
[units: participants]
  61     58     119  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     61     58     119  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  30.33  (3.63)     31.70  (4.28)     31.02  (3.96)  
Gender  
[units: participants]
     
Female     61     58     119  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Belgium     61     58     119  



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

2.  Secondary:   Pregnancy Rate   [ Time Frame: 12 weeks ]

3.  Secondary:   Good Embryo Quality   [ Time Frame: 3 days after oocyte retrieval ]

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

5.  Secondary:   Number of Cryopreserved Embryos   [ Time Frame: 1 week after oocyte retrieval ]

6.  Secondary:   Total Follicle Stimulating Hormone (FSH) Dose   [ Time Frame: 3 weeks ]

7.  Other Pre-specified:   Number of Days of Stimulation   [ Time Frame: 3 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: dr. Wim Decleer, PI
Organization: Fertility Center AZ Jan Palfijn
phone: 0032 9 325 92 20 ext 09/2248851
e-mail: wim.decleer@janpalfijngent.be


No publications provided


Responsible Party: Dr. Decleer Wim, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01682642     History of Changes
Other Study ID Numbers: 2012-000784-25
Study First Received: August 23, 2012
Results First Received: February 5, 2015
Last Updated: March 9, 2015
Health Authority: Belgium: Ethics Committee