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

NCT ID: NCT01682642

Last Updated: 2015-03-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zoladex

After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.

Group Type ACTIVE_COMPARATOR

Zoladex

Intervention Type DRUG

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

vaporization only

Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Zoladex

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Onze Lieve Vrouw Hospital

OTHER

Sponsor Role collaborator

AZ Jan Palfijn Gent

OTHER

Sponsor Role lead

Responsible Party

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Dr. Decleer Wim

gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wim Decleer, gynecologist

Role: PRINCIPAL_INVESTIGATOR

Fertility Center AZ Jan Palfijn Gent

Paul Devroey, Professor

Role: STUDY_CHAIR

Fertility Center AZ Jan Palfijn Gent

Locations

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AZ Jan Palfijn

Ghent, Oost-vlaanderen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2012-000784-25

Identifier Type: -

Identifier Source: org_study_id

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