Clinical and laboratory key performance indicators in IVF: A consensus between the Italian Society of Fertility and Sterility and Reproductive Medicine (SIFES-MR) and the Italian Society of Embryology, Reproduction and Research (SIERR).

PURPOSE: Infertility is increasing worldwide, and many couples seek IVF. Clinical management and laboratory work are fundamental in the IVF journey. Therefore, the definition of reliable key performance indicators (KPIs) based on clinical and laboratory parameters, is essential for internal quality control (IQC). Laboratory performance indicators have been identified and a first attempt to also determine clinical ones has been recently published. However, more detailed indicators are required. METHODS: An Italian group of experts in Reproductive Medicine from both public and private clinics on behalf of SIFES-MR and SIERR was established to define IVF indicators to monitor clinical performance. RESULTS: The working group built a consensus on a list of KPIs, performance indicators (PIs) and recommendation indicators (RIs). When deemed necessary, the reference population was stratified by woman age, response to ovarian stimulation and adoption of preimplantation genetic testing for aneuploidies (PGT-A). Each indicator was scored with a value from 1 to 5 and a weighted average formula - considering all the suggested parameters-was defined. This formula generates a center performance score, indicating low, average, good, or excellent performance. CONCLUSION: This study is intended to provide KPIs, PIs and RIs that encompass several essential aspects of a modern IVF clinic, including quality control and constant monitoring of clinical and embryological features. These indicators could be used to assess the quality of each center with the aim of improving efficacy and efficiency in IVF.

A prospective randomized noninferiority study comparing recombinant FSH and highly purified menotropin in intrauterine insemination cycles in couples with unexplained infertility and/or mild-moderate male factor.

OBJECTIVE: To demonstrate the noninferiority of highly purified menotropin (HP-hMG) compared with recombinant FSH (rFSH) regarding clinical pregnancy rate (PR) in intrauterine insemination (IUI) cycles. DESIGN: Prospective randomized noninferiority trial. SETTING: Unit of physiopathology of human reproduction, university hospital. PATIENT(S): Five hundred twenty-three patients with unexplained infertility or mild male infertility undergoing controlled ovarian hyperstimulation for IUI. INTERVENTION(S): Patients were randomized for treatment with rFSH (262 patients) or HP-hMG (261 patients). Insemination was performed 34-36 hours after hCG injection. MAIN OUTCOME MEASURE(S): The primary outcome was clinical pregnancy rate (PR). The secondary outcome was the number of interrupted cycles for high risk of ovarian hyperstimulation syndrome (OHSS) and multiple pregnancy. RESULT(S): The clinical PR was 19.7% (95% confidence interval [CI] 15.3%-25.1%) in the HP-hMG group and 21.4% (95% CI 16.9%-26.8%) in the rFSH group [absolute difference -1.7% (95% CI -8.6%-5.2%)]; therefore, the noninferiority was demonstrated. The number of interrupted cycles for OHSS risk and multiple pregnancy was significantLy higher in the rFSH group, 8.4% (95% CI 5.6%-12.4%) than in the HP-hMG group 1.2% (95% CI 0.4%-3.3%) [absolute difference -7.27% (95% CI -11.3 to -3.7)]. CONCLUSION(S): HP-hMG is not inferior compared with rFSH regarding clinical PR.

Suppression and recovery of gonadotropin and steroid secretion by a gonadotropin-releasing hormone receptor antagonist in healthy women with normal ovulation versus women with polycystic ovary syndrome in the early follicular phase.

OBJECTIVE: To evaluate the effects of the GnRH antagonist cetrorelix on the gonadal axis in patients with polycystic ovary syndrome (PCOS). DESIGN: Observational clinical study. SETTING: Academic research center. PATIENT(S): Ten patients with PCOS and 10 controls with normal ovulation. INTERVENTION(S): Patients received a daily cetrorelix injection (0.25 mg SC at 9:00 am) for 6 days, starting from day 3 of the menstrual cycle. MAIN OUTCOME MEASURE(S): Serum gonadotropin, E(2), T, 17-OH-P, and androstenedione plasma levels were evaluated at baseline and at 12 and 24 hours after each daily injection. These hormones were also assayed at days 10, 12, and 14 of the menstrual cycle. RESULT(S): We observed in patients with PCOS a significantly higher suppression of FSH and LH for the entire length of therapy; LH recovery secretion was significantly higher in the PCOS group. Regarding androgens, we found a greater suppression of T. Androstenedione and 17-OH-P showed a trend toward a higher suppression in PCOS. CONCLUSION(S): Gonadotropin and androgen suppression by GnRH antagonist is more effective in PCOS than in controls, suggesting a higher sensitivity of GnRH receptors in PCOS to this drug.