Essure multicenter off-label treatment for hydrosalpinx before in vitro fertilization

Literature Review Article

Essure multicenter off-label treatment for hydrosalpinx before in vitro fertilization.Galen DI, Khan N, Richter KS. J Minim Invasive Gynecol. 2011 May-Jun;18(3):338-42. Epub 2011 Mar 21.

Review
Paul C. Lin, M.D.
 

This is an observational study basically looking at the validity of the well-known contraceptive device Essure for treatment of hydrosalpinges. Hydrosalpinges are a well-known deterrant in pregnancy outcome for patients undergoing IVF due to the theory that the fluid in the tube is embryotoxic, and/or the fluid can potentially flush the embryos out of the uterus. Essure is a nonincisional procedure that involves an office-based hysteroscopic insertion of a small device called a microinsert into each fallopian tube that permanently occludes the proximal tube for contraceptive purposes, thereby preventing the fluid from interacting with the embryos.

In a 2 center, off-label, non-randomized study, 21 subjects were diagnosed with a hydrosalpinx (either bilateral or unilateral) based on laparoscopy or ultrasound criteria. With normal ovarian reserve, subjects underwent IVF after placement of the Essure device. There was birth rate per transfer of 57% and a birth rate of 67% per patient. When compared with the most recent 2009 SART database of IVF patients without hydrosalpinx, these rates were comparable. The authors concluded that Essure is less invasive when compared to the conventional treatment of surgical removal of the hydrosalpinx in question, but an equally effective method.

Of obvious concern about the microinserts is the potential exposure of the intrauterine portion of the insert that could create an inflammatory environment that decreases embryo implantation. In this observational study, the authors demonstrated that placement/appearance of 2-4 intrauterine coils, with resulting equivalent live-birth rates, is probably not clinically relevant. The authors also fully acknowledge that their study is a feasibility study, and that a randomized controlled trial (where the control group would be conventional salpingectomy) with enough power to demonstrate equivalent efficacy, would be the next step.

Comments
Daniel B. Williams, M.D.
 

It is well established that treatment of hydrosalpinges prior to IVF significantly improves outcome. Traditionally, this has been accomplished via laparoscopy. However, a less invasive approach is appealing, particularly for patients with a history of multiple pelvic surgeries and/or pelvic adhesions, who might have a higher complication rate with laparoscopy. This preliminary study would suggest that the Essure system may be a potential option to consider for this high-risk patient population, provided that appropriate counseling is given. Clearly, additional controlled trials with adequate power are required before offering this treatment routinely.

The above review and commentary on this article were written by SRS members.  Publication of these summaries does not reflect endorsement of any particular procedure or treatment.  Views expressed in these summaries do not necessarily reflect the views of SRS or ASRM.

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