Eighteen centers took part in this prospective study into which 930 eligible patients were recruited. The selection criteria for admission were atypical bleeding after at least 6 months of postmenopausal amenorrhea, and absence of hormonal therapies for at least 6 months. The sonographic measurement of the maximum bi-endometrial thickness was made in a longitudinal plane. Sonographic measurements were always performed within 3 days prior to histological evaluation. In these patients the mean number of years from menopause (25-75th centile) was 6 (range 2-16). The prevalence of endometrial carcinoma was 11.5% and the prevalence of atrophy was 49.2%. The area under the receiver operator characteristic curves generated by sonographic thickness measurements reached the level of 85%, both for cancer and atrophy. The likelihood ratio for cancer, yielded by an endometrial thickness of < or = 4.0 mm, was 0.05, and for atrophy it was 7.1. This cut-off of > 4.0 mm yielded a sensitivity for the detection of cancer of 98% and a negative predictive value of 99%. The overall sensitivity and positive predictive value for atrophy achieved by this cut-off were 57.2% and 87.3%, respectively. A multivariate logistic model showed that age and body mass index were independent variables associated with a significantly higher risk of endometrial cancer. The post-test probabilities for cancer and atrophy were recalculated on the basis of the integration of age, body mass index and endometrial thickness. The estimated reduction of invasive procedures on the basis of this integration was 31%. Transvaginal sonographic measurement of endometrial thickness, integrated with individual risk factors, can help in the management of postmenopausal patients with atypical bleeding, with regard to either the need for histological evaluation in high risk cases, or the choice of possible expectant management. We have shown that an endometrial thickness of < or = 4.0 mm safely predicts endometrial atrophy and justifies expectant management when the patient understands the need for proper follow up. This could be achieved with a reduction in the use of invasive procedures without unwanted delay in cancer diagnosis.

NCT03282279.

Objective: To study the actual controlled ovarian stimulation (COS) management in women with suboptimal response, comparing clinical outcomes to the gonadotropins consume, considering potential role of luteinizing hormone (LH) addition to follicle-stimulating hormone (FSH). Design: Monocentric, observational, retrospective, real-world, clinical trial on fresh intra-cytoplasmic sperm injection (ICSI) cycles retrieving from 1 to 9 oocytes, performed at Humanitas Fertility Center from January 1st, 2012 to December 31st, 2015. Methods: COS protocols provided gonadotropin releasing-hormone (GnRH) agonist long, flare-up, short and antagonist. Both recombinant and urinary FSH were used for COS and LH was added according to the clinical practice. ICSI outcomes considered were: gonadotropins dosages; total, mature, injected and frozen oocytes; cumulative, transferred and frozen embryos; implantation rate; pregnancy, delivery and miscarriage rates. Outcomes were compared according to the gonadotropin regimen used during COS. Results: Our cohort showed 20.8% of low responders, defined as 1–3 oocytes retrieved and 79.2% of “suboptimal” responders, defined as 4–9 oocytes retrieved. According to recent POSEIDON stratification, cycles were divided in group 1 (6.9%), 2 (19.8%), 3 (11.7%), and 4 (61.5%). The cohort was divided in 3 groups, according to the gonadotropin's regimen. Women treated with FSH plus LH showed worst prognostic factors, in terms of age, basal FSH, AMH, and AFC. This difference was evident in suboptimal responders, whereas only AMH and AFC were different among treatment groups in low responders. Although a different result, in terms of oocytes and embryos detected, major ICSI outcomes (i.e., pregnancy and delivery rates) were similar among groups of COS treatment. Outcomes were significantly different among Poseidon groups. Implantation, pregnancy and delivery rates were significantly higher in Poseidon group 1 and progressively declined in other POSEIDON groups, reaching the worst percentage in group 4. Conclusions: In clinical practice, women with worst prognosis factors are generally treated with a combination of LH and FSH. Despite low prognosis women showed a reduced number of oocytes retrieved, the final ICSI outcome, in terms of pregnancy, is similarly among treatment group. This result suggests that the LH addition to FSH during COS could improve the quality of oocytes retrieved, balancing those differences that are evident at baseline. Clinical Trial Registration: www.ClinicalTrials.gov , identifier: NCT03290911

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