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

Colorado Center for Reproductive Medicine

Status and phase: Completed; Phase 4

Conditions: Infertility; Endometriosis

Treatments: Other: No intervention; Drug: Leuprolide acetate in depot suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT00621179

IntegrinIVF

Details and patient eligibility

About

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

Full description

See summary

Enrollment: 37 patients

Sex: Female

Ages: 21 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

37 participants in 4 patient groups

Group 1

Active Comparator group

Description:

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

Treatment:

Other: No intervention

Group 2

Experimental group

Description:

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

Treatment:

Drug: Leuprolide acetate in depot suspension

Group 3

Experimental group

Description:

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

Treatment:

Drug: Leuprolide acetate in depot suspension

Group 4

Active Comparator group

Description:

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

Treatment:

Other: No intervention