Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with unexplained recurrent pregnancy loss: a protocol for a multicenter, randomized, double-blind, controlled trial
Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal-fetal immunological tolerance may play a key role in its pathogene...
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| Published in | Current controlled trials in cardiovascular medicine Vol. 26; no. 1; pp. 245 - 13 |
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| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
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England
BioMed Central Ltd
14.07.2025
BioMed Central BMC |
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| Abstract | Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal-fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice.
A randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 μg, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index.
This trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial.
ChiCTR2300077436. Prospectively registered on 2023-11-08. |
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| AbstractList | Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal-fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice.BACKGROUNDUnexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal-fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice.A randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 μg, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index.METHODSA randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 μg, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index.This trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial.DISCUSSIONThis trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial.ChiCTR2300077436. Prospectively registered on 2023-11-08.TRIAL REGISTRATIONChiCTR2300077436. Prospectively registered on 2023-11-08. Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal-fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice. A randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 μg, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index. This trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial. ChiCTR2300077436. Prospectively registered on 2023-11-08. Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal-fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice. A randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 [mu]g, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index. This trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial. Abstract Background Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1–2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal–fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice. Methods A randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 μg, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index. Discussion This trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial. Trial registration. ChiCTR2300077436. Prospectively registered on 2023–11-08. BackgroundUnexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1–2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal–fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice.MethodsA randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 μg, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index.DiscussionThis trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial.Trial registration.ChiCTR2300077436. Prospectively registered on 2023–11-08. Background Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal-fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice. Methods A randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 [mu]g, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index. Discussion This trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial. Trial registration. ChiCTR2300077436. Prospectively registered on 2023-11-08. Keywords: Granulocyte colony-stimulating factor, Unexplained recurrent pregnancy loss, Randomized controlled trial, Pregnancy outcome |
| ArticleNumber | 245 |
| Audience | Academic |
| Author | Zeng, Xianghui Zhou, Qi Mu, Fangxiang Cai, Zhuhua Chen, Yaolong Du, Lirong Wang, Fang |
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| Keywords | Granulocyte colony-stimulating factor Randomized controlled trial Pregnancy outcome Unexplained recurrent pregnancy loss |
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| References_xml | – volume: 3 start-page: 1032212 year: 2022 ident: 8951_CR3 publication-title: Frontiers in global women's health doi: 10.3389/fgwh.2022.1032212 – volume: 19 start-page: 44 issue: 1 year: 2021 ident: 8951_CR5 publication-title: Reproductive biology and endocrinology : RB&E doi: 10.1186/s12958-021-00728-x – ident: 8951_CR29 doi: 10.1016/j.biopha.2022.112903 – volume: 13 year: 2022 ident: 8951_CR6 publication-title: Front Endocrinol – volume: 21 start-page: 34 issue: 1 year: 2023 ident: 8951_CR11 publication-title: Reproductive biology and endocrinology : RB&E doi: 10.1186/s12958-023-01063-z – volume: 18 start-page: 379 issue: 4 year: 2017 ident: 8951_CR33 publication-title: Journal of reproduction & infertility – volume: 34 start-page: 602 issue: 8 year: 2015 ident: 8951_CR31 publication-title: Chinese Journal of New Drugs and Clinical Remedies – volume: 19 start-page: 125 issue: 1 year: 2021 ident: 8951_CR13 publication-title: Reproductive biology and endocrinology : RB&E doi: 10.1186/s12958-021-00810-4 – volume: 35 start-page: 791 issue: 11 year: 2015 ident: 8951_CR23 publication-title: Reproduction and Contraception – volume: 3 year: 2019 ident: 8951_CR9 publication-title: European journal of obstetrics & gynecology and reproductive biology: X – volume: 40 start-page: 1589 issue: 7 year: 2023 ident: 8951_CR19 publication-title: J Assist Reprod Genet doi: 10.1007/s10815-023-02827-7 – ident: 8951_CR4 doi: 10.3390/ijms241713071 – ident: 8951_CR21 doi: 10.3390/genes11040354 – volume: 34 start-page: 602 issue: 8 year: 2015 ident: 8951_CR22 publication-title: Chinese Journal of New Drugs and Clinical Remedies – volume: 16 start-page: 246 issue: 3 year: 2023 ident: 8951_CR8 publication-title: Journal of human reproductive sciences doi: 10.4103/jhrs.jhrs_8_23 – volume: 306 start-page: 1281 issue: 4 year: 2022 ident: 8951_CR20 publication-title: Arch Gynecol Obstet doi: 10.1007/s00404-022-06663-5 – ident: 8951_CR2 doi: 10.3390/jcm12124074 – volume: 24 start-page: 2703 issue: 11 year: 2009 ident: 8951_CR16 publication-title: Human reproduction (Oxford, England) doi: 10.1093/humrep/dep240 – volume: 11 start-page: 20298 issue: 1 year: 2021 ident: 8951_CR26 publication-title: Sci Rep doi: 10.1038/s41598-021-98606-4 – volume: 156 year: 2023 ident: 8951_CR18 publication-title: J Reprod Immunol – volume: 20 start-page: 10 issue: 1 year: 2019 ident: 8951_CR30 publication-title: BMC Immunol doi: 10.1186/s12865-019-0290-3 – ident: 8951_CR24 doi: 10.1016/S0140-6736(20)30925-9 – ident: 8951_CR28 doi: 10.3390/ijms242417336 – volume: 22 start-page: 44 issue: 1 year: 2024 ident: 8951_CR12 publication-title: Reproductive biology and endocrinology : RB&E doi: 10.1186/s12958-024-01221-x – volume: 20 start-page: 722 issue: 4 year: 1998 ident: 8951_CR25 publication-title: Clin Ther doi: 10.1016/S0149-2918(98)80135-5 – volume: 12 year: 2021 ident: 8951_CR7 publication-title: Front Immunol – volume: 16 issue: 10 year: 2024 ident: 8951_CR27 publication-title: Cureus – ident: 8951_CR14 doi: 10.3390/life13051097 – volume-title: Evaluation value of peripheral blood neutrophils combined with IL-10 on the efficacy of G-CSF in recurrent abortion year: 2019 ident: 8951_CR15 – ident: 8951_CR32 – volume: 34 start-page: 424 issue: 3 year: 2019 ident: 8951_CR17 publication-title: Hum Reprod doi: 10.1093/humrep/dey393 – ident: 8951_CR1 doi: 10.1093/hropen/hoad002 – ident: 8951_CR10 doi: 10.1002/14651858.CD000112.pub3 |
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| Snippet | Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women... Background Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2%... BackgroundUnexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1–2%... Abstract Background Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects... |
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| SubjectTerms | Abortion, Habitual - diagnosis Abortion, Habitual - drug therapy Abortion, Habitual - prevention & control Adult Autoimmune diseases Birth rate Care and treatment China Clinical medicine Congenital diseases Disease Diseases Double-Blind Method Evidence-based medicine Female Gestational Age Granulocyte colony-stimulating factor Granulocyte Colony-Stimulating Factor - administration & dosage Granulocyte Colony-Stimulating Factor - adverse effects Granulocyte Colony-Stimulating Factor - therapeutic use Granulocytes Hospitals Humans Immunology Informed consent Leukocytes Medical research Medicine, Experimental Multicenter Studies as Topic Neutrophils Patient safety Pregnancy Pregnancy outcome Pregnant women Randomized controlled trial Randomized Controlled Trials as Topic Recombinant Proteins - administration & dosage Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Relapse Reproductive health Study Protocol Time Factors Treatment Outcome Unexplained recurrent pregnancy loss Uterus Womens health |
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| Title | Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with unexplained recurrent pregnancy loss: a protocol for a multicenter, randomized, double-blind, controlled trial |
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