FS Reports最新文献

{"title":"Efficacy and safety of desogestrel/ethinylestradiol 150/20 flexible extended regimen (FREEDOM 150/20) in dysmenorrhea: phase 3 study in Japan","authors":"Kaori Koga M.D., Ph.D.,&nbsp;Daniela Colaci M.D., MSc, Dr.PH.,&nbsp;Madeline Grigg M.D.,&nbsp;Daisuke Goto Ph.D.,&nbsp;Tinghui Yu Ph.D.,&nbsp;Mikio Momoeda M.D., Ph.D.","doi":"10.1016/j.xfre.2026.06.003","DOIUrl":"10.1016/j.xfre.2026.06.003","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the efficacy and long-term safety of a user-driven flexible extended regimen of desogestrel 150 μg/ethinylestradiol 20 μg (DSG/EE 150/20) for the treatment of primary or secondary dysmenorrhea in women from Japan.</div></div><div><h3>Design</h3><div>Phase 3, randomized, placebo-controlled, parallel-group, double-blind study with an open-label extension period.</div></div><div><h3>Subjects</h3><div>Two hundred and eleven women with regular menstrual cycles and primary or secondary dysmenorrhea in 21 centres across Japan.</div></div><div><h3>Intervention</h3><div>Participants were randomly assigned (3:1) to receive DSG/EE 150/20 μg or placebo once daily for 24–80 consecutive days, with each treatment period followed by a 4-day tablet-free interval. After the double-blind phase (three 28-day cycles), participants entered an open-label phase (≤10 cycles); participants initially receiving placebo were switched to DSG/EE.</div></div><div><h3>Main Outcome Measures</h3><div>Primary endpoint was change from baseline through day 84 in total dysmenorrhea score (TDS). Secondary endpoints included number of days with dysmenorrheic pain, patient global impression of change (PGI-C), treatment satisfaction questionnaire for medication (TSQM-9), quality of life (QoL) measured by the 36-item short form health survey version 2.0 (SF-36v2), and safety outcomes.</div></div><div><h3>Results</h3><div>In the 211 participants randomized to DSG/EE (n = 159) and placebo (n = 52), the mean (SD) age was 32.3 (7.56) years, and body mass index was 21.94 (3.18). A significant reduction in TDS from baseline through day 84 was observed in the DSG/EE group vs. placebo (least squares mean: −2.50 vs. −0.84; treatment difference [95% confidence interval: −1.67 [−2.08, −1.26]). The number of days with mild, moderate, and severe pain were 12.9 vs. 12.1, 4.8 vs. 6.5, and 0.8 vs. 1.1 days in the DSG/EE vs. placebo group. Over 80% of DSG/EE-treated participants reported improvement in PGI-C scores compared with &lt;30% on placebo. TSQM-9 global satisfaction and effectiveness least squares mean scores were higher with DSG/EE (63.69 vs. 36.62 and 62.86 vs. 35.5) compared with placebo. DSG/EE improved SF-36v2 scores, particularly in the physical component summary, bodily pain, and role-physical domains. Overall, the most frequent treatment-emergent adverse events were intermenstrual bleeding, nasopharyngitis, and nausea. No deaths were reported during the entire study period.</div></div><div><h3>Conclusion</h3><div>DSG/EE 150/20 effectively reduced dysmenorrhea severity, improved SF-36v2 scores and treatment satisfaction, offered dosing flexibility, and was well-tolerated with a safety profile consistent with combined oral contraceptives.</div></div><div><h3>Trial Registration</h3><div>jRCT2031230276 (<span><span>https://jrct.mhlw.go.jp/en-latest-detail/jRCT2031230276</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 4","pages":"Pages 313-321"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148718652","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commentary on “Do children born after embryo vitrification differ from siblings born after fresh embryo transfer?”","authors":"Amit Jaiswal M.D.","doi":"10.1016/j.xfre.2026.02.013","DOIUrl":"10.1016/j.xfre.2026.02.013","url":null,"abstract":"","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 4","pages":"Page 333"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148718653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trigger failure, intraoperative recovery, and the cognitive architecture of clinical decision-making in in vitro fertilization: a case for integrative education in reproductive medicine","authors":"Lionel Reyftmann M.D., D.E.S.C. Med. Reprod.,&nbsp;Dean Morbeck Ph.D., M.B.A.","doi":"10.1016/j.xfre.2026.05.004","DOIUrl":"10.1016/j.xfre.2026.05.004","url":null,"abstract":"","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 4","pages":"Pages 338-339"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148718659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Cardinal protocol: investigating a simplified, cost-conscious option for oocyte cryopreservation in a prospective noninferiority cohort study","authors":"Esther H. Chung M.D.,&nbsp;Natasha Raj-Derouin M.D.,&nbsp;Jiaqi Zhang M.S.,&nbsp;Victoria Harbour M.S.,&nbsp;Metabel Markwei M.D.,&nbsp;Arian Khorshid M.D.,&nbsp;Brindha Bavan M.D., M.S.,&nbsp;Lusine Aghajanova M.D. Ph.D.,&nbsp;Ruth B. Lathi M.D.","doi":"10.1016/j.xfre.2026.05.001","DOIUrl":"10.1016/j.xfre.2026.05.001","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;div&gt;To determine if the novel cost-conscious and simplified Cardinal protocol could achieve noninferior clinical outcomes in planned oocyte cryopreservation (OC) cycles, compared with routine protocols.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Design&lt;/h3&gt;&lt;div&gt;Prospective noninferiority cohort study, nonrandomized&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Subjects&lt;/h3&gt;&lt;div&gt;Patients undergoing planned OC were prospectively recruited at a single academic institution between July 2023 and August 2024.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Exposure&lt;/h3&gt;&lt;div&gt;Participants self-selected between the routine protocols vs. the Cardinal protocol. All participants paid for their cycles out-of-pocket or using insurance. The Cardinal protocol is limited to 2 ultrasounds (baseline and stimulation day [SD] 9, no bloodwork, standardized follicle-stimulating hormone (FSH) dosing (antimüllerian hormone ≤ 4: 300 IU, antimüllerian hormone &gt; 4: 225 IU), scheduled progestin start on SD6 in place of an antagonist, and autotrigger when ≥3 follicles are projected to be ≥18 mm. Routine protocols (antagonist, microdose flare) include up to maximum-dose gonadotropins, 5–6 ultrasounds, and 3–5 blood draws.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Main Outcome Measures&lt;/h3&gt;&lt;div&gt;The primary outcome was the number of mature metaphase II oocytes (MIIs) retrieved. Secondary outcomes included the total number of oocytes retrieved and cryopreserved, premature ovulation, ovarian hyperstimulation syndrome (OHSS), cycle cancellation, and postretrieval surgical complications. Total charges including the cost of medications were noted. A postcycle survey compared satisfaction and sociodemographic factors influencing patient choice between the Cardinal vs. routine protocols.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Of 118 total participants, 60 enrolled in Cardinal and 58 opted for routine. No significant differences (i.e., in age, body mass index, race/ethnicity) existed between groups. A total of 137 cycles (70 Cardinal and 67 routine) were compared. The mean difference in MIIs between groups was +1.08 (95% CI −1.1 to 3.27), demonstrating noninferiority of the Cardinal protocol. Premature ovulation did not occur in either group. The OHSS rates were lower in Cardinal (2.9% vs. 23%); no other significant differences in adverse events were noted. The median charge for a Cardinal cycle was $5,004 lower than that of routine protocols. Postcycle surveys (73% response rate) demonstrated higher satisfaction with Cardinal at 85% vs. 65%, driven by cost and convenience.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;The Cardinal protocol appears to be a noninferior option to routine protocols. It considerably reduced charges by $5,000 without a decrease in MIIs retrieved, making it a cost-conscious protocol that should be seriously considered for OC cycles. The Cardinal protocol was overall satisfactory for patients who selected this over the routine protocols, notably across diverse sociodemographic groups.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Trial registration&lt;/h3&gt;&lt;div&gt;NCT05","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 4","pages":"Pages 301-312"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148718532","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A new tool requires a new approach: glucagon-like peptide-1 receptor agonists and the scope of fertility care","authors":"Wendy S. Vitek M.D.,&nbsp;Kassie J. Bollig M.D., M.S.C.E.","doi":"10.1016/j.xfre.2026.06.005","DOIUrl":"10.1016/j.xfre.2026.06.005","url":null,"abstract":"","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 4","pages":"Pages 267-268"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148718533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mature oocyte retrieval without an exogenous trigger during random-start stimulation in a very early intrauterine pregnancy: a case report","authors":"Mohammad Saaed ElFarran M.D., M.Sc.,&nbsp;Karolina Palinska-Rudzka M.D., M.R.C.O.G.,&nbsp;Raj Mathur M.D., F.R.C.O.G.","doi":"10.1016/j.xfre.2026.04.003","DOIUrl":"10.1016/j.xfre.2026.04.003","url":null,"abstract":"<div><h3>Objective</h3><div>To describe a rare case of mature oocyte retrieval without an exogenous trigger during random-start controlled ovarian stimulation (RS-COS) coinciding with a very early intrauterine pregnancy.</div></div><div><h3>Design</h3><div>Case report.</div></div><div><h3>Subject</h3><div>A 32-year-old para 1 patient with inflammatory breast cancer (grade 3, T4N2M0, ER/PR negative, HER2 3+, Ki-67 60%).</div></div><div><h3>Exposure</h3><div>Luteal-phase RS-COS using a gonadotropin-releasing hormone antagonist protocol with human menopausal gonadotropin (hMG) 300 IU daily. Egg retrieval was performed on day 12 after stimulation.</div></div><div><h3>Main Outcome Measures</h3><div>Number and maturity of oocytes retrieved; occurrence of ovarian hyperstimulation syndrome (OHSS).</div></div><div><h3>Results</h3><div>On day 10 of stimulation, 25 follicles measuring ≥12 mm were seen, of which 18 were in the right ovary. A gestational sac was seen in the uterine cavity. The serum human chorionic gonadotropin level was 2,563 IU/L. Oocyte retrieval from the right ovary was performed without administering a trigger. Nine metaphase II oocytes were retrieved and vitrified; mild clinical OHSS occurred.</div></div><div><h3>Conclusion</h3><div>This case demonstrates that it may be possible to perform COS in early pregnancy and be able to retrieve mature oocytes without the use of an exogenous trigger. To our knowledge, there are no previous published reports of multiple metaphase II oocyte retrieval without an exogenous trigger during RS-COS.</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 4","pages":"Pages 327-331"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148718656","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply of the authors: Response to Letter to the Editor","authors":"Peter Lindner M.D.,&nbsp;Kerry Flannagan Ph.D.,&nbsp;Howard J. Li M.D.,&nbsp;Jerry Wang M.S.,&nbsp;Luis R. Hoyos M.D.,&nbsp;Meike Uhler M.D.,&nbsp;Michael Homer M.D.,&nbsp;Kate Devine M.D.,&nbsp;Micah Hill M.D.,&nbsp;Phillip Romanski M.D., M.Sc.","doi":"10.1016/j.xfre.2026.03.010","DOIUrl":"10.1016/j.xfre.2026.03.010","url":null,"abstract":"","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 4","pages":"Page 337"},"PeriodicalIF":2.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148718658","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Moving from subjectivity to standardization? The emerging role of artificial intelligence in the embryology laboratory","authors":"Rachel A. Martel M.D. ,&nbsp;Jason Franasiak M.D., H.C.L.D.","doi":"10.1016/j.xfre.2026.04.011","DOIUrl":"10.1016/j.xfre.2026.04.011","url":null,"abstract":"","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 3","pages":"Pages 180-181"},"PeriodicalIF":2.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148241745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Embryologist experience affects concordance with an artificial intelligence embryo ranking algorithm: benefit of artificial intelligence assistance","authors":"Jørgen Berntsen M.Sc. ,&nbsp;Philip Marsh M.Sc. ,&nbsp;Brendan Burkart B.A. ,&nbsp;Mark G. Larman Ph.D. ,&nbsp;Martin N. Johansen Ph.D. ,&nbsp;Mitchell Rosen M.D., HCLD","doi":"10.1016/j.xfre.2026.04.002","DOIUrl":"10.1016/j.xfre.2026.04.002","url":null,"abstract":"<div><h3>Objective</h3><div>To study the concordance between artificial intelligence (AI) algorithm selection and manual embryo selection, and how the concordance depends on the experience levels of embryologists.</div></div><div><h3>Design</h3><div>Retrospective observational study.</div></div><div><h3>Subjects</h3><div>A total of 1,321 preimplantation genetic testing for aneuploidy (PGT-A) tested cycles from 1,165 patients with at least one transferred euploid embryo.</div></div><div><h3>Exposure</h3><div>Embryo ranking was performed both manually and using an AI algorithm.</div></div><div><h3>Main Outcome Measures</h3><div>The concordance rate between embryologists and an AI algorithm.</div></div><div><h3>Results</h3><div>The overall concordance rate was 58.6% (95% confidence interval [CI]: 55.9%–61.2%) and increased with embryologist experience: Junior (51.3%, 95% CI: 44.3%–58.2%), Senior (57.1%, 95% CI: 53.3%–61.0%), and Senior+ (63.4%, 95% CI: 59.2%–67.7%). The fetal heartbeat (FHB) rates were 68.3% (95% CI: 65.1%–71.6%) in the concordant group and 66.5% (95% CI: 62.6%–70.5%) in the discordant group. The odds ratio between the two groups was not statistically significant, however when adjusting for the number of usable embryos, age and oocyte source, the odds ratio was significant.</div></div><div><h3>Conclusion</h3><div>The concordance levels between embryologists and an AI algorithm depended significantly on the level of experience. The study also indicated that adjunctive use could potentially increase clinical outcomes.</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 3","pages":"Pages 188-194"},"PeriodicalIF":2.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148247243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Catheter contamination during embryo transfer: impact on outcomes of in vitro fertilization","authors":"Asma Boughanmi M.D. ,&nbsp;Manel Hamdoun M.D. ,&nbsp;Marouen Braham M.D. ,&nbsp;Khadija Kacem Berjeb M.D. ,&nbsp;Sana Chtourou M.D. ,&nbsp;Mounir Ben Mefteh M.D. ,&nbsp;Anis Fadhlaoui M.D. ,&nbsp;Nozha Chakroun M.D. ,&nbsp;Moez Kdous M.D. ,&nbsp;Olfa Bahri M.D.","doi":"10.1016/j.xfre.2026.03.003","DOIUrl":"10.1016/j.xfre.2026.03.003","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the impact of embryo transfer catheter contamination on in vitro fertilization outcomes.</div></div><div><h3>Design</h3><div>Prospective analytical observational study conducted over a period of 2 years and 9 months (from January 2021 to September 2023).</div></div><div><h3>Subjects</h3><div>Women aged ≤42 years with a sonographically normal uterus, undergoing fresh or frozen embryo transfer with good-quality embryos.</div></div><div><h3>Exposure</h3><div>Microbial contamination of the embryo transfer catheter was assessed by culture and real-time polymerase chain reaction. Vaginal and cervical samples were also analyzed by culture.</div></div><div><h3>Main Outcome Measures</h3><div>Embryo transfer catheter contamination rate and its association with in vitro fertilization outcomes (pregnancy and live birth rates).</div></div><div><h3>Results</h3><div>A total of 210 patients were included, 50% of whom underwent fresh embryo transfer. The rates of pregnancy and live birth were 29% and 17.5%, respectively. Culture-based analysis showed that 33.8% of catheters were contaminated with cervicovaginal microorganisms other than lactobacilli; this contamination rate was 3 times higher in fresh transfers. Positive catheter cultures were associated with significantly lower pregnancy and live birth rates (8.5% vs. 39.6% and 4.2% vs. 24.4%, respectively). The main bacterial species isolated were <em>Streptococcus agalactiae</em> (n = 31), <em>Actinomyces</em> spp. (n = 9), and <em>Gardenerella vaginalis</em> (n = 8). Conversely, the presence and abundance of <em>Lactobacillus</em> species on the catheter tip were associated with improved in vitro fertilization outcomes. Polymerase chain reaction detected <em>Gardenerella vaginalis</em> and urogenital mycoplasmas in 31.9% and 13.8% of patients, respectively. Overall, when all methods were combined, catheter contamination was observed in 58.1% of cases; it was 6 times higher in women with bacterial vaginosis. In multivariate analysis, a positive catheter culture was the only independent factor associated with failure to achieve pregnancy and live birth.</div></div><div><h3>Conclusion</h3><div>Catheter contamination, particularly by cultivable microorganisms other than <em>Lactobacillus</em> species, constitutes an independent factor associated with in vitro fertilization failure. Guidelines for infertility management should be updated to include both clinical and microbiological parameters to enhance assisted reproductive technologies’ diagnostic and therapeutic strategies.</div></div>","PeriodicalId":34409,"journal":{"name":"FS Reports","volume":"7 3","pages":"Pages 216-223"},"PeriodicalIF":2.2,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148247575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}