Objective To evaluate the efficacy of ubrogepant on patient‐reported functional disability, satisfaction with study medication, and global impression of change. Background Ubrogepant is a small‐molecule, oral calcitonin gene‐related peptide receptor antagonist indicated for the acute treatment of migraine. In 2 phase 3 trials (ACHIEVE I and II), ubrogepant demonstrated efficacy vs placebo on the 2 co‐primary endpoints of headache pain freedom and absence of the most bothersome migraine‐associated symptom at 2 hours post dose for the 50 and 100 mg doses. Patient‐reported outcomes, such as functional disability, satisfaction, and patient global impression of change, can provide additional evidence of the efficacy of an acute treatment for migraine on clinically meaningful and patient‐relevant outcomes. Methods ACHIEVE I and ACHIEVE II were multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group, single‐attack trials in adults (18‐75 years) with migraine. In ACHIEVE I, participants were randomized 1:1:1 to placebo or ubrogepant 50 or 100 mg; in ACHIEVE II, participants were randomized 1:1:1 to placebo or ubrogepant 25 or 50 mg to treat a migraine attack with moderate or severe headache pain. Participants rated ability to perform daily activities on the Functional Disability Scale, before dosing and at 1, 2, 4, and 8 hours after the initial dose; satisfaction with study medication at 2 and 24 hours; and impression of overall change in migraine on the Patient Global Impression of Change scale at 2 hours. In prespecified analyses for each trial, each outcome was compared between each ubrogepant dose group and the relevant placebo group. Data were pooled from the ubrogepant 50 mg and placebo groups of the 2 trials in a post hoc analysis. Results In ACHIEVE I, 559 participants were randomized to placebo, 556 to ubrogepant 50 mg, and 557 to ubrogepant 100 mg; in ACHIEVE II, 563 were randomized to placebo, 561 to ubrogepant 25 mg, and 562 to ubrogepant 50 mg. At 2 hours post dose, significantly higher proportions of ubrogepant‐treated participants vs placebo‐treated participants reported being able to function normally (ACHIEVE I: ubrogepant 50 mg, 40.6% [171/421], P = .0012 vs placebo; ubrogepant 100 mg, 42.9% [192/448], P < .0001 vs placebo; placebo, 29.8% [136/456]; ACHIEVE II: ubrogepant 25 mg, 42.6% [185/434], P = .0015 vs placebo; ubrogepant 50 mg, 40.5% [188/464], P = .0118 vs placebo; placebo, 34.2% [156/456]; pooled 50 mg, 40.6% [359/885], vs pooled placebo, 32.0% [292/912]; P < .0001), were satisfied/extremely satisfied with study medication (ACHIEVE I: 50 mg, 36.3% [147/405], P < .0001 vs placebo; 100 mg, 35.8% [149/416], P = .0002 vs placebo; placebo, 24.1% [104/432]; ACHIEVE II: 25 mg, 35.1% [141/402], P = .0018 vs placebo; 50 mg, 37.8% [163/431], P < .0001 vs placebo; placebo, 24.8% [106/427]; pooled ubrogepant 50 mg, 37.1% [310/836], vs pooled placebo, 24.5% [210/859]; P < .0001), and indicated that their migraine was much/very much better on the Patient Global Impression of Change scale (A...

In the EM from HPE, IL-8 is associated with higher pregnancy rates, higher IRs, and higher N LBPP, so IL-8 may be an independent predictor for pretransfer assessment of the embryo development potential in IVF patients.

Objective: To investigate the prevalence and the related characteristics of oligomenorrhea among women within childbearing age in China. Study design: A large-scale community-based investigation was conducted from 2013 to 2015. A total of 12,964 women aged 18–49 years from 9 provinces/municipalities in China were recruited for healthcare screening in local community health centers. Outcome measures include clinical history, ultrasonographic exam, and hormonal and metabolic parameters. Results: Among women within childbearing age in China, the prevalence of oligomenorrhea was 12.2% (1,579/12,964). Both sociodemographic factors and medical history were significantly associated with oligomenorrhea ( P < 0.05). In such women, the prevalence of obesity, acne, seborrhea, acanthosis, larger ovarian size, and polycystic ovarian morphology was higher when compared with normal women; the prevalence of anti-Mullerian hormone, total testosterone, and androstenedione ( P < 0.05) was higher as well. The infertility rates of all women were higher in the oligomenorrhea group (17.2%, 272⁄1,579) than in the non-oligomenorrhea group (9.0%, 1,024⁄11,385), and among women without contraception, for the oligomenorrhea group, the infertility rate was 32.5% (128⁄394), and for the non-oligomenorrhea group, 17.9% (400⁄2,240). In the oligomenorrhea group, 57.4% (156/272) of the women underwent treatments for infertility, which was higher than the non-oligomenorrhea group 36.1% (370/1,024). Conclusions: Obesity, acne, seborrhea, acanthosis, larger ovarian size, and polycystic ovarian morphology were significantly associated with oligomenorrhea. The increase of anti-Mullerian hormone, total testosterone, and androstenedione level was also demonstrated in the oligomenorrhea group. Higher prevalence of infertility and medical treatment rate was observed in women with oligomenorrhea.

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