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

Infertility Clinical Trial

— IntegrinIVF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621179
• Other study ID #: IntegrinIVF
• Status: Completed
• Phase: Phase 4
• Start date: March 2003
• Est. completion date: January 2010

Study information

• Verified date: August 2021
• Source: Colorado Center for Reproductive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

See summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Infertility

Intervention

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

Other:
• No intervention

Locations

Country	Name	City	State
United States	Colorado Center for Reproductive Medicine	Lone Tree	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado Center for Reproductive Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lessey BA, Castelbaum AJ, Sawin SW, Buck CA, Schinnar R, Bilker W, Strom BL. Aberrant integrin expression in the endometrium of women with endometriosis. J Clin Endocrinol Metab. 1994 Aug;79(2):643-9. — View Citation

Surrey ES, Silverberg KM, Surrey MW, Schoolcraft WB. Effect of prolonged gonadotropin-releasing hormone agonist therapy on the outcome of in vitro fertilization-embryo transfer in patients with endometriosis. Fertil Steril. 2002 Oct;78(4):699-704. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.