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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01682642
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : March 20, 2015
Last Update Posted : March 20, 2015
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Infertility
Intervention: Drug: Zoladex

  Participant Flow

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
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Reporting Groups
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 

  Baseline Characteristics

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

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 
Overall Participants Analyzed 
[Units: Participants]
 61   58   119 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   61   58   119 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 30.33  (3.63)   31.70  (4.28)   31.02  (3.96) 
[Units: Participants]
Female   61   58   119 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
Belgium   61   58   119 

  Outcome Measures

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

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

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

Responsible Party: Dr. Decleer Wim, AZ Jan Palfijn Gent Identifier: NCT01682642     History of Changes
Other Study ID Numbers: 2012-000784-25
First Submitted: August 23, 2012
First Posted: September 11, 2012
Results First Submitted: February 5, 2015
Results First Posted: March 20, 2015
Last Update Posted: March 20, 2015