Back to resultsThe Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
Primary Purpose
Infertility, Endometriosis
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Zoladex
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring endometriosis, pregnancy, In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI), peritoneal implants, embryo quality
Eligibility 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
Sites / Locations
- AZ Jan Palfijn
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Zoladex
vaporization only
Arm Description
After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Outcomes
Primary Outcome Measures
Number of Metaphase II Cells (MII)
number of MII cells retrieved
Secondary Outcome Measures
Pregnancy Rate
The number of ongoing pregnancies obtained which still is the most important issue for the patients.
Good Embryo Quality
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)
number of 2PN
Number of Cryopreserved Embryos
number of blastocytes that can be cryopreserved
Total Follicle Stimulating Hormone (FSH) Dose
total dose of FSH needed at the end of stimulation
Full Information
NCT ID
NCT01682642
First Posted
August 23, 2012
Last Updated
March 9, 2015
Sponsor
AZ Jan Palfijn Gent
Collaborators
Onze Lieve Vrouw Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01682642
Brief Title
The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Jan Palfijn Gent
Collaborators
Onze Lieve Vrouw Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Endometriosis
Keywords
endometriosis, pregnancy, In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI), peritoneal implants, embryo quality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zoladex
Arm Type
Active Comparator
Arm Description
After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
Arm Title
vaporization only
Arm Type
No Intervention
Arm Description
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Intervention Type
Drug
Intervention Name(s)
Zoladex
Intervention Description
after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment
Primary Outcome Measure Information:
Title
Number of Metaphase II Cells (MII)
Description
number of MII cells retrieved
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Pregnancy Rate
Description
The number of ongoing pregnancies obtained which still is the most important issue for the patients.
Time Frame
12 weeks
Title
Good Embryo Quality
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
Title
Number of Pro Nuclear Cell (2PN)
Description
number of 2PN
Time Frame
1 day after oocyte retrieval
Title
Number of Cryopreserved Embryos
Description
number of blastocytes that can be cryopreserved
Time Frame
1 week after oocyte retrieval
Title
Total Follicle Stimulating Hormone (FSH) Dose
Description
total dose of FSH needed at the end of stimulation
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Number of Days of Stimulation
Description
number of days needed before follicles in the ovary are mature for oocyte retrieval
Time Frame
3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Decleer, gynecologist
Organizational Affiliation
Fertility Center AZ Jan Palfijn Gent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Devroey, Professor
Organizational Affiliation
Fertility Center AZ Jan Palfijn Gent
Official's Role
Study Chair
Facility Information:
Facility Name
AZ Jan Palfijn
City
Gent
State/Province
Oost-vlaanderen
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
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