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.|
|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|
|Actual Primary Completion Date :||October 2014|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|