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

This study has been completed.
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent Identifier:
First received: August 23, 2012
Last updated: March 9, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Drug: Zoladex
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:

Further study details as provided by AZ Jan Palfijn Gent:

Primary Outcome Measures:
  • Number of Metaphase II Cells (MII) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    number of MII cells retrieved

Secondary Outcome Measures:
  • 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

Other Outcome Measures:
  • 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

Enrollment: 120
Study Start Date: March 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zoladex
After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.
Drug: Zoladex
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.


Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01682642

AZ Jan Palfijn
Gent, Oost-vlaanderen, Belgium, 9000
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
Principal Investigator: Wim Decleer, gynecologist Fertility Center AZ Jan Palfijn Gent
Study Chair: Paul Devroey, Professor Fertility Center AZ Jan Palfijn Gent
  More Information

No publications provided

Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent Identifier: NCT01682642     History of Changes
Other Study ID Numbers: 2012-000784-25
Study First Received: August 23, 2012
Results First Received: February 5, 2015
Last Updated: March 9, 2015
Health Authority: Belgium: Ethics Committee

Keywords provided by AZ Jan Palfijn Gent:
In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI)
peritoneal implants
embryo quality

Additional relevant MeSH terms:
Genital Diseases, Female
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Pharmacologic Actions
Therapeutic Uses processed this record on November 24, 2015