The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
|ClinicalTrials.gov Identifier: NCT01682642|
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : March 20, 2015
Last Update Posted : March 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infertility Endometriosis||Drug: Zoladex||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2012|
|Primary Completion Date :||October 2014|
|Study Completion Date :||October 2014|
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.
- Number of Metaphase II Cells (MII) [ Time Frame: 3 weeks ]number of MII cells retrieved
- Pregnancy Rate [ Time Frame: 12 weeks ]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 ]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 ]number of 2PN
- Number of Cryopreserved Embryos [ Time Frame: 1 week after oocyte retrieval ]number of blastocytes that can be cryopreserved
- Total Follicle Stimulating Hormone (FSH) Dose [ Time Frame: 3 weeks ]total dose of FSH needed at the end of stimulation
- Number of Days of Stimulation [ Time Frame: 3 weeks ]number of days needed before follicles in the ovary are mature for oocyte retrieval
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|