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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2010-01-31

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

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Detailed Description

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Conditions

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Endometriosis Infertility

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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Group 1

Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

Group 2

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

Group Type EXPERIMENTAL

Leuprolide acetate in depot suspension

Intervention Type DRUG

Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3

Group 3

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

Group Type EXPERIMENTAL

Leuprolide acetate in depot suspension

Intervention Type DRUG

Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3

Group 4

Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

Interventions

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Leuprolide acetate in depot suspension

Leuprolide acetate in depot suspension 3.75 mg intramuscularly every 28 days x 3

Intervention Type DRUG

No intervention

Intervention Type OTHER

Other Intervention Names

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Depot Lupron

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No