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

March 9, 2015 updated by: Dr. Decleer Wim, AZ Jan Palfijn Gent

IVF Outcome in Patients With Peritoneal Endometriosis. The Impact of a Hormonal Treatment of the Endometriosis Prior to the IVF on the Pregnancy Rates.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-vlaanderen
      • Gent, Oost-vlaanderen, Belgium, 9000
        • AZ Jan Palfijn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Metaphase II Cells (MII)
Time Frame: 3 weeks
number of MII cells retrieved
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Rate
Time Frame: 12 weeks
The number of ongoing pregnancies obtained which still is the most important issue for the patients.
12 weeks
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.
3 days after oocyte retrieval
Number of Pro Nuclear Cell (2PN)
Time Frame: 1 day after oocyte retrieval
number of 2PN
1 day after oocyte retrieval
Number of Cryopreserved Embryos
Time Frame: 1 week after oocyte retrieval
number of blastocytes that can be cryopreserved
1 week after oocyte retrieval
Total Follicle Stimulating Hormone (FSH) Dose
Time Frame: 3 weeks
total dose of FSH needed at the end of stimulation
3 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Days of Stimulation
Time Frame: 3 weeks
number of days needed before follicles in the ovary are mature for oocyte retrieval
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Jan Palfijn Gent

Collaborators

Onze Lieve Vrouw Hospital

Investigators

  • Principal Investigator: Wim Decleer, gynecologist, Fertility Center AZ Jan Palfijn Gent
  • Study Chair: Paul Devroey, Professor, Fertility Center AZ Jan Palfijn Gent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-000784-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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