The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Number of Metaphase II Cells (MII) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]number of MII cells retrieved
- 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
- 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
|Study Start Date:||March 2012|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Zoladex
After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment
No Intervention: vaporization only
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682642
|AZ Jan Palfijn|
|Gent, Oost-vlaanderen, Belgium, 9000|
|Principal Investigator:||Wim Decleer, gynecologist||Fertility Center AZ Jan Palfijn Gent|
|Study Chair:||Paul Devroey, Professor||Fertility Center AZ Jan Palfijn Gent|