{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T13:00:45Z","timestamp":1765890045968,"version":"3.48.0"},"reference-count":28,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2023,12,30]],"date-time":"2023-12-30T00:00:00Z","timestamp":1703894400000},"content-version":"unspecified","delay-in-days":29,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100012899","name":"Lanzhou University","doi-asserted-by":"publisher","award":["YJS-BD-17"],"award-info":[{"award-number":["YJS-BD-17"]}],"id":[{"id":"10.13039\/100012899","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,9,25]]},"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Approximately 17.5% of couples of reproductive age have experienced infertility. Women with a poor ovarian response (POR) must undergo in vitro fertilisation (IVF) and embryo transfer to achieve pregnancy. However, studies have reported a poor response to gonadotropin stimulation in women undergoing IVF-ET. Results from animal experiments suggest that granulocyte colony-stimulating factor (G-CSF) has a curative effect by protecting ovarian function, reducing follicle loss and delaying premature ovarian failure in rats caused by chemotherapy. Clinical studies on the therapeutic effect of G-CSF are deficient; therefore, this study will investigate its ability to improve ovum quality and maturity among women with POR undergoing IVF\/intracytoplasmic sperm injection (ICSI).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This clinical, multicentre, triple-blind, placebo-controlled trial will employ balanced randomisation (1:1). The planned sample size is 312 participants (156 subjects in each group). A total of 312 patients with infertility undergoing IVF\/ICSI will be recruited from four public hospitals in China. The participants will be randomly divided into an experimental group (G-CSF) and a placebo group (control). All patients will be treated by using the progestin-primed ovarian stimulation superovulation protocol. The primary outcome will be D3 embryo quality. The number of ova obtained, MII ova and transferable embryos will be inclusive in the secondary outcome.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>To our knowledge, this is the first clinical trial to investigate the effect of G-CSF treatment timing and stimulation protocol in patients with POR in China. This study will provide new information about G-CSF efficacy among patients with POR undergoing IVF\/ICSI and can help improve ovum quality and maturity. Clinical trials on this subject are deficient in China; therefore, a well-designed randomised trial is needed to determine the ability of G-CSF to improve ovum quality and maturity to facilitate conception among women with POR treated with IVF\/ICSI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ChiCTR2200062412.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-074135","type":"journal-article","created":{"date-parts":[[2023,12,30]],"date-time":"2023-12-30T08:50:47Z","timestamp":1703926247000},"page":"e074135","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with poor ovarian response: protocol for a multicentre, randomised, controlled trial"],"prefix":"10.1136","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6392-9672","authenticated-orcid":false,"given":"Xianghui","family":"Zeng","sequence":"first","affiliation":[{"name":"Department of Reproductive Medicine, Lanzhou University Second Hospital, Lanzhou, China"},{"name":"Reproductive Center, Qinghai Province People\u2019s Hospital, Xining, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lirong","family":"Du","sequence":"additional","affiliation":[{"name":"Hebei Key Laboratory of Reproductive Medicine, Hebei Reproductive Health Hospital, Shijiazhuang, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huilin","family":"Yang","sequence":"additional","affiliation":[{"name":"Qinghai Red Cross Hospital, Xining, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7895-374X","authenticated-orcid":false,"given":"Fang","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Reproductive Medicine, Lanzhou University Second Hospital, Lanzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2023,12,30]]},"reference":[{"key":"2025121604544192000_13.12.e074135.1","unstructured":"Infertility prevalence estimates, 1990\u20132021. 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