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

NCT00621179 | Completed Phase 4 Results DMC

• 1 other identifier: IntegrinIVF
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Endometriosis; Infertility

Keywords

Endometriosis,infertility,in vitro fertilization

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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

Other: No intervention

Group 2

EXPERIMENTAL

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

Group 3

EXPERIMENTAL

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

Group 4

ACTIVE COMPARATOR

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

Interventions

Leuprolide acetate in depot suspension DRUG

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

Also known as: Depot Lupron

Group 2; Group 3

No intervention OTHER

Group 1; Group 4

Eligibility Criteria

• Age: 21 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertility
• Surgical diagnosis of endometriosis
• Normal ovarian reserve testing
• Regular menses

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado Center for Reproductive Medicine: lead

Study Sites (1)

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, 80124, United States

Location

Related Publications (3)

• 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. doi: 10.1016/s0015-0282(02)03373-3.

  PMID: 12372443 BACKGROUND

• 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. doi: 10.1210/jcem.79.2.7519194.

  PMID: 7519194 BACKGROUND

• Surrey ES, Lietz AK, Gustofson RL, Minjarez DA, Schoolcraft WB. Does endometrial integrin expression in endometriosis patients predict enhanced in vitro fertilization cycle outcomes after prolonged GnRH agonist therapy? Fertil Steril. 2010 Feb;93(2):646-51. doi: 10.1016/j.fertnstert.2008.12.023. Epub 2009 Jan 26.

  PMID: 19171333 DERIVED

MeSH Terms

Conditions

Endometriosis; Infertility

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Eric Surrey
• Organization: Colorado Center for Reproductive Medicine

esurrey@colocrm.com

303-788-8300

Study Officials

• Eric S Surrey, M.D.

  Colorado Center for Reproductive Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2003
• Primary Completion: August 1, 2009
• Study Completion: January 1, 2010
• Last Updated: August 10, 2021
• Results First Posted: October 5, 2020

Record last verified: 2021-08

Locations

US (1)