NCT01682642

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 20, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

August 23, 2012

Results QC Date

February 5, 2015

Last Update Submit

March 9, 2015

Conditions

InfertilityEndometriosis

Keywords

endometriosispregnancyIn Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI)peritoneal implantsembryo quality

Outcome Measures

Primary Outcomes (1)

  • Number of Metaphase II Cells (MII)

    number of MII cells retrieved

    3 weeks

Secondary Outcomes (5)

  • Pregnancy Rate

    12 weeks

  • Good Embryo Quality

    3 days after oocyte retrieval

  • Number of Pro Nuclear Cell (2PN)

    1 day after oocyte retrieval

  • Number of Cryopreserved Embryos

    1 week after oocyte retrieval

  • Total Follicle Stimulating Hormone (FSH) Dose

    3 weeks

Other Outcomes (1)

  • Number of Days of Stimulation

    3 weeks

Study Arms (2)

Zoladex

ACTIVE COMPARATOR

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

Drug: Zoladex

vaporization only

NO INTERVENTION

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

Interventions

ZoladexDRUG

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

Zoladex

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • laparoscopical vaporization of endometriosis
  • ,2, 3e IVF cycle
  • endometriosis stage I and II
  • younger than 38 years

You may not qualify if:

  • endometriosis cysts
  • uterine pathology
  • endocrinological diseases and problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Jan Palfijn

Ghent, Oost-vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

InfertilityEndometriosis

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Results Point of Contact

Title
dr. Wim Decleer, PI
Organization
Fertility Center AZ Jan Palfijn
wim.decleer@janpalfijngent.be
0032 9 325 92 20

Study Officials

  • Wim Decleer, gynecologist

    Fertility Center AZ Jan Palfijn Gent

    PRINCIPAL INVESTIGATOR

  • Paul Devroey, Professor

    Fertility Center AZ Jan Palfijn Gent

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
gynecologist

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 11, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 20, 2015

Results First Posted

March 20, 2015

Record last verified: 2015-03

Locations

BE(1)