Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF

Study Overview
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Brief Summary
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This prospective randomized trial evaluates whether one can predict which infertile women with endometriosis who are candidates for in vitro fertilization will benefit from prolonged therapy with a GnRH agonist by the determination of the absence of endometrial expression of the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for in vitro fertilization and then undergo randomization to a three month course of a depot preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian stimulation or standard therapy. prio

Detailed Description
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See summary

Official Title
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Do Endometrial Implantation Markers Predict in Vitro Fertilization-embryo Transfer Cycle Outcomes in Endometriosis Patients Pretreated With Leuprolide Acetate in Depot Suspension?

Conditions
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Endometriosis, Infertility

Intervention / Treatment
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* Drug: Leuprolide acetate in depot suspension
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertility Surgical diagnosis of endometriosis Normal ovarian reserve testing Regular menses Exclusion Criteria: Irregular menses Undiagnosed abnormal uterine bleeding Pregnancy Prior adverse reaction to any GnRH agonist Ovarian cystic or solid mass > 3cm in mean diameter at study entry Use of a depot preparation of a GnRh agonist or any hormonal therapy for endometriosis within 6 months of study entry Current hepatic, renal, hematologic or psychiatric disorder

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 42 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: Group 1<br>Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention | Other: No intervention<br> <br> |
| Experimental: Group 2<br>Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation followed by in vitro fertilization | Drug: Leuprolide acetate in depot suspension<br>* Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3<br>* Other names: Depot Lupron;|
| Experimental: Group 3<br>Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation | Drug: Leuprolide acetate in depot suspension<br>* Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3<br>* Other names: Depot Lupron;|
| Active Comparator: Group 4<br>Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention | Other: No intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Who Responded to Controlled Ovarian Hyperstimulation | Number of patients who responded to controlled ovarian stimulation as evidenced by implantation of embryo. Implantation confirmed by ultrasound at 6 1/2 weeks of pregnancy. | Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis,infertility,in vitro fertilization