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

• Published in: Current controlled trials in cardiovascular medicine Vol. 26; no. 1; pp. 245 - 13
• Main Authors: Mu, Fangxiang, Cai, Zhuhua, Du, Lirong, Zeng, Xianghui, Zhou, Qi, Chen, Yaolong, Wang, Fang
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 14.07.2025; BioMed Central; BMC
• Subjects: 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; China; Granulocyte colony-stimulating factor; Randomized controlled trial; Pregnancy outcome; Unexplained recurrent pregnancy loss

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...