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Study on the effect and mechanism of recombinant human granulocyte colony stimulating factor in patients with recurrent pregnancy loss

Study on the effect and mechanism of recombinant human granulocyte colony stimulating factor in patients with recurrent pregnancy loss

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100328
Enrollment
Unknown
Registered
2025-04-08
Start date
2024-12-18
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent pregnancy loss

Interventions

Experimental group:Recombinant human granulocyte colony stimulating factor medication

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Recurrent spontaneous abortion: 2 or more consecutive pregnancy losses with the same sexual partner before 24 weeks of pregnancy; 2. Gestation days: 30-45 days (based on the last menstrual period); 3. Natural pregnancy; 4. Diagnosis of pregnancy is based on ultrasound results; 5. Age: 20-35 years old; 6. BMI: 18.5–24 kg/m2;

Exclusion criteria

Exclusion criteria: 1.Those who do not meet the inclusion criteria; 2.Those who refuse to sign informed consent; 3. Chromosomal abnormality in either spouse: The chromosome test result shall prevail; array-CGH in the last miscarriage showed abnormal fetal karyotype; 4.Abnormal uterine anatomical structure: the results of hysteroscopy/B-ultrasound shall prevail; 5.Female infertility: The couple has regular sexual intercourse for 1 year, without contraception and no pregnancy; 6. Endocrine and metabolic abnormalities (1) Hyperprolactinemia: serological test (2) Cushing's syndrome: typical clinical symptoms and signs, such as central obesity, purple lines, increased hair, sexual dysfunction, fatigue, etc. Urinary 17-hydroxycorticosteroid excretion was significantly increased, which could not be inhibited by low-dose dexamethasone suppression test. Elevated blood 11-hydroxycorticosteroid levels and loss of circadian rhythm (3) Premature ovarian failure: oligomenorrhea or amenorrhea for at least 4 months; FSH > 25IU/L twice at random (interval > 4 weeks); 7. Abnormal blood routine: abnormal white blood cells and platelets (before medication); 8. Recent (within 90 days) medication history: excluding folic acid tablets, multivitamin tablets and combined auxiliary medications; 9. Basic diseases of the heart, brain, lung, liver, kidney, etc.: medical history and liver and kidney function, cardiopulmonary function; 10. Abnormal infection indicators: AIDS, syphilis, hepatitis, tuberculosis, secretions, toxoplasmosis, cytomegalovirus, herpes virus; 11. History of malignant tumors; 12.Allergic diseases or allergic constitution: medical history, allergic to any rhG-CSF drug or any E. coli derived protein; 13. Smoking and severe alcoholism;

Design outcomes

Primary

MeasureTime frame
Embryo survival rate at 20 weeks of gestation;

Secondary

MeasureTime frame
Embryo survival rate at 28 weeks of gestation;Live birth rate;Gestational age at delivery;Embryo survival rate at 12 weeks of gestation;Complications of childbirth;

Countries

China

Contacts

Public ContactPengsheng Zheng

The First Affiliated Hospital of Xi'an Jiaotong University

zpsheng@mail.xjtu.edu.cn+86 29 85323215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026