Back to resultsPentoxifylline and Endometriosis (LETS1)
Primary Purpose
Endometriosis-Associated Infertility
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
pentoxifylline
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis-Associated Infertility focused on measuring endometriosis, immunomodulation, infertility, laparoscopic surgery, pentoxifylline
Eligibility Criteria
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
Sites / Locations
- Hospital Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Pregnancy rate
Secondary Outcome Measures
Full Information
NCT ID
NCT00632697
First Posted
March 4, 2008
Last Updated
March 10, 2008
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT00632697
Brief Title
Pentoxifylline and Endometriosis
Acronym
LETS1
Official Title
Combined Laparoscopic Surgery and Pentoxifylline Therapy for Treatment of Endometriosis-Associated Infertility: A Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis-Associated Infertility
Keywords
endometriosis, immunomodulation, infertility, laparoscopic surgery, pentoxifylline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pentoxifylline
Intervention Description
800 mg daily for six months
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
6 months follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
18487215
Citation
Creus M, Fabregues F, Carmona F, del Pino M, Manau D, Balasch J. Combined laparoscopic surgery and pentoxifylline therapy for treatment of endometriosis-associated infertility: a preliminary trial. Hum Reprod. 2008 Aug;23(8):1910-6. doi: 10.1093/humrep/den167. Epub 2008 May 16.
Results Reference
derived
Learn more about this trial
Pentoxifylline and Endometriosis
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