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NCT00632697 Clinical Trial

Pentoxifylline and Endometriosis

Endometriosis-Associated Infertility Clinical Trial

— LETS1  

Official title:
Combined Laparoscopic Surgery and Pentoxifylline Therapy for Treatment of Endometriosis-Associated Infertility: A Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00632697
Other study ID # LETS
Secondary ID
Status Completed
Phase Phase 3
First received March 4, 2008
Last updated March 10, 2008
Start date October 2001
Est. completion date December 2006

Study information
Verified date March 2008
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Infertile patients having early endometriosis as the only factor of their infertility

Exclusion Criteria:

- Previous treatment for endometriosis or patients having pelvic disorders in addition to endometriosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• pentoxifylline
800 mg daily for six months
• placebo

Locations
Country Name City State
Spain Hospital Clinic Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy rate 6 months follow-up No