Polycystic Ovary Syndrome (PCOS), the most common endocrinopathy affecting reproductive-aged women, is characterized by oligo-/anovulation, hyperandrogenism and polycystic ovaries. In PCOS women with anovulatory infertility, the accepted first-line treatment is clomiphene citrate (CC). For patients resistant to CC, laparoscopic ovarian drilling (LOD) is recommended as a second-line therapy. Whilst very effective, LOD is an invasive technique requiring general anaesthesia and associated with a significant risk of postoperative adhesions. The aim of the study was to evaluate the feasibility and safety of a new transvaginal ovarian drilling procedure in a bovine model. Thirteen female cattle aged 38 years were selected to have ovarian morphology and size similar to human PCOS ovaries. The procedure was performed under light epidural anaesthesia using the AblaCare Kit, comprising a device (an ablation catheter deployed through a needle) mounted on a vaginal ultrasound probe, and a radiofrequency energy generator. After transvaginal introduction of the probe, the needle was inserted into each ovary and the catheter released to deliver 46 ablations/ovary. Animal sacrifice or ovariectomies were performed on day 0, 7, 36, 6972 of the procedure to harvest ovaries and reproductive tract. The procedure was successfully completed in all animals without any sign of pain or significant discomfort. Before performing ablations, the needle and catheter were easily visualised and located within the ovary by ultrasound. No adverse events or significant technical difficulties occurred during or after procedure, demonstrating good feasibility. From a safety standpoint, the macroscopic analysis of the harvested ovaries showed no adhesions or damage to the ovarian surface aside from the needle puncture. Thermal lesions were confined to the ablation zones at days 0 (n=3) and 7 (n=4) and their volume amounted to 5.74% and 5.20% of the total ovarian volume respectively, in line with target volume reduction known to achieve efficacy of ovarian drilling. No lesions were visible at days 36 and 6972 (n=3 both, P<0.001). The ovarian structure was conserved, and no damage secondary to ablation or puncture was found in surrounding organs. All animals, monitored by ultrasound after procedure, maintained normal cycles with no disruption of folliculogenesis/corpus luteum development. The technical feasibility and safety of this novel procedure, ovarian rebalancing, using a dedicated device were successfully assessed in the bovine model. These preclinical results need to be validated in a clinical trial in anovulatory PCOS women, that will additionally allow to evaluate the efficacy in terms of ovulation induction.
18 - 21 May 2019
European Society of Endocrinology