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

Study Overview
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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.

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

Conditions
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Infertility, Endometriosis

Intervention / Treatment
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* Drug: Zoladex


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zoladex<br>After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. | Drug: Zoladex<br>* after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment<br>|
| No Intervention: vaporization only<br>Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, pregnancy, In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI), peritoneal implants, embryo quality