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Hum. Reprod. Advance Access originally published online on May 16, 2008
Human Reproduction 2008 23(8):1910-1916; doi:10.1093/humrep/den167
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© The Author 2008. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Combined laparoscopic surgery and pentoxifylline therapy for treatment of endometriosis-associated infertility: a preliminary trial

Montserrat Creus, Francisco Fábregues, Francisco Carmona, Marta del Pino, Dolors Manau and Juan Balasch1

Institut Clinic of Obstetrics, Gynaecology and Neonatology, Faculty of Medicine-University of Barcelona, Hospital Clínic - Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), c/ Casanova 143, 08036-Barcelona, Spain

1 Correspondence address. E-mail: jbalasch{at}ub.edu

BACKGROUND: Surgical treatment has modest efficacy for the treatment of infertility associated with early-stage endometriosis. Immunomodulation with pentoxifylline is considered as a new strategy potentially useful in treating endometriosis. Thus, this study investigated the usefulness of combined laparoscopic surgery and pentoxifylline therapy in the treatment of infertility associated with minimal to mild endometriosis.

METHODS: A prospective, randomized, controlled blind trial was conducted. Patients entered the study immediately after laparoscopic surgery and were randomly assigned to the treatment with either oral pentoxifylline (800 mg/day) (pentoxifylline group, n = 51) or an oral placebo (placebo group, n = 53). Patients were then observed for pregnancy for 6 months.

RESULTS: Among 98 patients finally considered in the evaluation of the results, the 6 month overall pregnancy rates were 28 and 14% in the pentoxifylline and placebo groups, respectively. Thus, an absolute difference of 14% (95% CI –2 to 30) (Chi-squared test, P = 0.1) in the cumulative probability of pregnancy in 6 months after laparoscopic surgery in patients receiving pentoxifylline versus placebo post-operatively was observed.

CONCLUSION: Our findings provide preliminary clinical evidence to suggest the new experimental treatment approaches, toward endometriosis, that are based on immunomodulation deserve further attention. Well-designed multicenter trials are warranted to confirm or refute our results.

The ClinicalTrials.gov Identifier is NCT00632697 [ClinicalTrials.gov] .

Key words: endometriosis/immunomodulation/infertility/laparoscopic surgery/pentoxifylline

Submitted on November 24, 2007; resubmitted on March 17, 2008; accepted on April 8, 2008.


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