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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Infertility
Endometriosis
Intervention Drug: Zoladex
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zoladex Vaporization Only
Hide Arm/Group Description After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment. After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment).
Period Title: Overall Study
Started 61 59
Completed 61 58
Not Completed 0 1
Arm/Group Title Zoladex Vaporization Only Total
Hide Arm/Group Description

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

Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment. Total of all reporting groups
Overall Number of Baseline Participants 61 58 119
Hide Baseline Analysis Population Description
women between 18 and 38 years
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
61
 100.0%
58
 100.0%
119
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 58 participants 119 participants
30.33  (3.63) 31.70  (4.28) 31.02  (3.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
Female
61
 100.0%
58
 100.0%
119
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Belgium Number Analyzed 61 participants 58 participants 119 participants
61 58 119
1.Primary Outcome
Title Number of Metaphase II Cells (MII)
Hide Description number of MII cells retrieved
Time Frame 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zoladex Vaporization Only
Hide Arm/Group Description:

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

Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Overall Number of Participants Analyzed 61 58
Mean (Standard Deviation)
Unit of Measure: MII cells
8.2  (5.92) 8.2  (4.82)
2.Secondary Outcome
Title Pregnancy Rate
Hide Description The number of ongoing pregnancies obtained which still is the most important issue for the patients.
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zoladex Vaporization Only
Hide Arm/Group Description:

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

Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Overall Number of Participants Analyzed 61 58
Measure Type: Number
Unit of Measure: percentage of ongoing pregnancies
39.3 39.7
3.Secondary Outcome
Title Good Embryo Quality
Hide Description 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.
Time Frame 3 days after oocyte retrieval
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zoladex Vaporization Only
Hide Arm/Group Description:
After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVF treatment.
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Overall Number of Participants Analyzed 61 58
Measure Type: Number
Unit of Measure: percentage of good quality embryos
59.3 67.3
4.Secondary Outcome
Title Number of Pro Nuclear Cell (2PN)
Hide Description number of 2PN
Time Frame 1 day after oocyte retrieval
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zoladex Vaporization Only
Hide Arm/Group Description:
[Not Specified]
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Overall Number of Participants Analyzed 61 58
Mean (Standard Deviation)
Unit of Measure: number of pro nuclear cells
5.4  (4.03) 5.6  (4.20)
5.Secondary Outcome
Title Number of Cryopreserved Embryos
Hide Description number of blastocytes that can be cryopreserved
Time Frame 1 week after oocyte retrieval
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zoladex Vaporization Only
Hide Arm/Group Description:
After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVFtreatment.
Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
Overall Number of Participants Analyzed 61 58
Mean (Standard Deviation)
Unit of Measure: number of cryopreserved embryos
0.9  (1.40) 1.6  (2.31)
6.Secondary Outcome
Title Total Follicle Stimulating Hormone (FSH) Dose
Hide Description total dose of FSH needed at the end of stimulation
Time Frame 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zoladex Vaporization Only
Hide Arm/Group Description:
After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following ivf treatment.
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Overall Number of Participants Analyzed 61 58
Mean (Standard Deviation)
Unit of Measure: IUs
2561  (621.7) 2303  (604.8)
7.Other Pre-specified Outcome
Title Number of Days of Stimulation
Hide Description number of days needed before follicles in the ovary are mature for oocyte retrieval
Time Frame 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zoladex Vaporization Only
Hide Arm/Group Description:
After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start IVF treatment.
Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
Overall Number of Participants Analyzed 61 58
Mean (Standard Deviation)
Unit of Measure: days
12.3  (1.86) 11.3  (1.98)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zoladex Vaporization Only
Hide Arm/Group Description

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

Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
All-Cause Mortality
Zoladex Vaporization Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zoladex Vaporization Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/61 (18.03%)      7/58 (12.07%)    
Reproductive system and breast disorders     
OHSS  [1]  11/61 (18.03%)  7/58 (12.07%) 
Indicates events were collected by systematic assessment
[1]
Ovary Hyper Stimulation Syndrome (OHSS)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Zoladex Vaporization Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/61 (1.64%)      0/58 (0.00%)    
Surgical and medical procedures     
miscarriage  [1]  1/61 (1.64%)  1 0/58 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
pregnancy lost in first trimester
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
ClinicalTrials.gov 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