Self-Administered Vaginal Sonograms Effective in Assisted Reproduction

July 28, 2014

By Bridgett Novak

NEW YORK (Reuters Health) - Women undergoing assisted reproduction can monitor their own follicular phase endovaginally as effectively as health care personnel, according to a new study.

During the ovarian stimulation phase, frequent vaginal sonograms are necessary to assess the number and size of the patient's follicles, so her daily dose of gonadotrophins can be adjusted, if necessary, and to determine when HCG injections should be given. Early signs of ovarian hyperstimulation syndrome (OHSS) can also be detected.

To determine if these sonograms can be performed successfully by the patients themselves, Jan Gerris and colleagues at Ghent University Hospital in Belgium enrolled 123 women, all under 41, with two ovaries, who were undergoing intracytoplasmic sperm injection (ICSI).

Participants were randomized into two groups: 59 were taught to use self-operated endovaginal telemonitoring equipment (SOET); the other 62 had endovaginal ultrasonography done by a healthcare worker (non-SOET). Both groups were comparable with respect to age, partner's age, BMI, smoking behavior, and duration of subfertility.

Patients in the SOET group were taught to use a vaginal sonography probe to record 2D images of their uterus and ovaries and to upload and transmit those images via computer. They were given a laptop equipped with the necessary software. The program was developed by the Engineering Department at Ghent University and by Laborie in Canada. The images were read and interpreted by the study authors. Patients were then instructed to either continue on the same hormone regimen or adjust their hormones, and they were scheduled for their next sonogram. If their follicles were mature, plans were made for an HCG injection, and the patient returned the computer equipment.

Clinical outcomes were not statistically different between the two groups. The median number of metaphase-II oocytes picked up by ultrasound in the SOET group was eight versus seven in the non-SOET group. Twenty-five percent of the SOET group had ongoing pregnancies compared to 26% of the non-SOET group.

In addition, all patients were asked to assess their and their partner's satisfaction with the process, their feelings of empowerment, whether their partner actively participated, their feelings of stress, and concerns over discretion. Women in the SOET group consistently ranked five of these more positively than women in the non-SOET group. The exception was stress. Almost all of the participants said they experienced stress about the process of follicle monitoring and ovarian stimulation, the organizational and logistical factors involved, and the use of a novel technique. Women in the SOET group said their stress was reduced as they learned how to properly use the probe and their follicles became more visible.

The average total cost per SOET attempt (455 Euros; US$611) was approximately half that of the non-SOET approach (894 Euros; US$1200). This included loss of productivity at work and transportation costs to the center, which were much higher for the non-SOET group.

Though researchers had hoped to have a larger sample size, they believe this study still demonstrated that SOET is as effective as non-SOET for the monitoring of ovarian stimulation in ART patients and at half the price.

Dr. Gerris directed Reuters Health to Sonaura LLC for comment.

Sonaura LLC has bought the licensing rights to the system. Patrick Bols, the CEO of Sonaura, told Reuters Health in a phone interview that several IVF centers in Belgium and France have already purchased it and are offering it as an option to their ART/IVF patients. Sonaura is currently analyzing the U.S. market to determine a marketing strategy and hopes to be able to launch in the U.S. in early 2015.

SOURCE: http://bit.ly/1l1LeRz

Hum Repro 2014.

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