The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.

Infertility Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682642
• Other study ID #: 2012-000784-25
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2012
• Last updated: March 9, 2015
• Start date: March 2012
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: AZ Jan Palfijn Gent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Infertility

Intervention

Drug:
• Zoladex
after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment

Locations

Country	Name	City	State
Belgium	AZ Jan Palfijn	Gent	Oost-vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
AZ Jan Palfijn Gent	Onze Lieve Vrouw Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Days of Stimulation	number of days needed before follicles in the ovary are mature for oocyte retrieval	3 weeks	No
Primary	Number of Metaphase II Cells (MII)	number of MII cells retrieved	3 weeks	No
Secondary	Pregnancy Rate	The number of ongoing pregnancies obtained which still is the most important issue for the patients.	12 weeks	No
Secondary	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.	3 days after oocyte retrieval	No
Secondary	Number of Pro Nuclear Cell (2PN)	number of 2PN	1 day after oocyte retrieval	No
Secondary	Number of Cryopreserved Embryos	number of blastocytes that can be cryopreserved	1 week after oocyte retrieval	No
Secondary	Total Follicle Stimulating Hormone (FSH) Dose	total dose of FSH needed at the end of stimulation	3 weeks	No