{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,7]],"date-time":"2025-10-07T00:48:10Z","timestamp":1759798090736,"version":"build-2065373602"},"reference-count":24,"publisher":"S. Karger AG","issue":"5","license":[{"start":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T00:00:00Z","timestamp":1739491200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T00:00:00Z","timestamp":1739491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Gynecol Obstet Invest"],"abstract":"<jats:p>Objectives: This study aimed to explore potential differences in efficacy between vaginal progesterone (VPG) and VPG + oral progesterone (OPG) for luteal-phase support in hormone replacement therapy-frozen embryo transfer (HRT-FET) cycles. Design: A single-centre, open-label, randomized controlled, phase IV pilot study was conducted. Participants\/Materials, Setting, Methods: Infertile women aged 20\u201338 years undergoing HRT-FET cycles were included. Participants were randomized to VPG (n = 86) or VPG + OPG (n = 86). The primary efficacy endpoint was ongoing pregnancy at 10\u201312 weeks. Secondary efficacy endpoints included \u03b2-human chorionic gonadotropin (\u03b2-hCG) positivity, implantation rate, and clinical-pregnancy rate. Safety analyses included adverse events (AE) and vital signs. Results: A higher ongoing pregnancy rate was observed with VPG + OPG (29.1%) versus VPG (18.8%); treatment difference 8.4% (90% confidence interval [CI] \u22122.2%, 19.0%). Numerical differences also favoured VPG + OPG over VPG for \u03b2-hCG positivity (0.9% [90% CI: \u221210.8%, 12.7%]), implantation (10.4% [90% CI: 0.5%, 21.3%]), and clinical pregnancy (10.1% [90% CI: \u22120.8%, 21.1%]). Incidences of treatment-emergent AEs were comparable. Limitations: The single-centre study was limited by a relatively small sample size which could have impacted the reported outcomes. Another limitation was the open-label design, which might have increased the risk of bias for subjective endpoints, such as AE reporting. Conclusions: A higher ongoing pregnancy rate was observed with VPG + OPG vs VPG; however, a statistical conclusion cannot be reached considering the small sample size. These data suggest that a minimum daily progesterone dose, such as VPG 90 mg + OPG 20 mg reported here, or VPG 180 mg reported in other studies, may be required for successful outcomes following HRT-FET cycles. <\/jats:p>","DOI":"10.1159\/000544065","type":"journal-article","created":{"date-parts":[[2025,2,15]],"date-time":"2025-02-15T12:00:56Z","timestamp":1739620856000},"page":"492-503","source":"Crossref","is-referenced-by-count":0,"title":["Progesterone Vaginal Gel or Combined Medication for Luteal-Phase Support of Frozen-Thawed Embryo Transfer Cycles: A Single-Centre, Chinese, Randomized, Open-Label, Pilot Study"],"prefix":"10.1159","volume":"90","author":[{"given":"Ningning","family":"Pan","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiumei","family":"Zhen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yanhong","family":"Fan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jianhuai","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuanyuan","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiao","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xun","family":"Liao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rui","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"127","published-online":{"date-parts":[[2025,2,14]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2020.00458"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2021.03.039"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/dey388"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1093\/humupd\/dmy033"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1016\/j.rbmo.2020.04.021"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1016\/j.bpobgyn.2020.05.005"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.3389\/frph.2022.919948"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2021.07.002"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.3760\/cma.j.issn.0529-567X.2016.07.001"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0133027"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780040211"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.18502\/ijrm.v19i9.9708"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1016\/j.rbmo.2012.10.012"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1007\/s00404-016-4217-4"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2021.04.013"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/deab093"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.3389\/fendo.2023.1128564"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1016\/j.fertnstert.2022.12.035"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/del117"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/dey306"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1186\/s12958-021-00696-2"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.1016\/s0015-0282(00)00518-5"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.29271\/jcpsp.2021.03.278"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1705334"}],"container-title":["Gynecologic and Obstetric Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/goi\/article-pdf\/doi\/10.1159\/000544065\/4339774\/000544065.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/karger.com\/article-pdf\/doi\/10.1159\/000544065","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,6]],"date-time":"2025-10-06T16:06:28Z","timestamp":1759766788000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000544065"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,14]]},"references-count":24,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2025,10,6]]},"published-print":{"date-parts":[[2025,10,8]]}},"URL":"https:\/\/doi.org\/10.1159\/000544065","archive":["Portico"],"relation":{},"ISSN":["0378-7346","1423-002X"],"issn-type":[{"type":"print","value":"0378-7346"},{"type":"electronic","value":"1423-002X"}],"subject":[],"published":{"date-parts":[[2025,2,14]]}}}