Intrauterine G-CSF Infusion for Thin Endometrium

Starting soon · Phase 3

Conditions studied: Thin Endometrium, Female Infertility

In brief

Thin endometrium is a condition in which the lining of the uterus is too thin during preparation for embryo transfer. This may reduce the chance of pregnancy and live birth in patients undergoing frozen-thawed embryo transfer. This study will evaluate whether intrauterine infusion of granulocyte colony-stimulating factor, also called G-CSF, can improve pregnancy outcomes in patients with thin endometrium. Participants will be randomly assigned to one of two groups. The experimental group will receive mild endometrial stimulation followed by intrauterine infusion of G-CSF 300 μg. The control group will receive the same mild endometrial stimulation followed by intrauterine infusion of normal saline. Both groups will then continue standard endometrial preparation for frozen-thawed embryo transfer. The main outcome of the study is the live birth rate. The study will also assess endometrial thickness, endometrial blood flow, clinical pregnancy rate, miscarriage rate, and safety outcomes, including adverse events, pregnancy complications, fetal malformations, and neonatal birth defects. Participants will be followed from enrollment through embryo transfer, pregnancy assessment, and delivery. This is a single-center, prospective, randomized controlled trial conducted at Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School. The planned sample size is 620 participants.

Key facts

Study ID

NCT07692672

Run by

Nanjing University

People needed

620

Starts

2026-10-01

Expected to finish

2029-08-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 39. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients aged 18 to <40 years.
• Patients with normal ovarian function.
• History of endometrial thickness ≤7 mm in at least one previous endometrial preparation cycle.
• At least two good-quality embryos remaining.
• Fewer than 3 previous embryo transfer cycles.
• Willing and able to provide written informed consent.

You may not qualify if…

• Uterine diseases or conditions that may affect the uterine cavity, including intramural uterine fibroids affecting the uterine cavity, severe adenomyosis, endometriosis, uterine malformation, endometrial tuberculosis, or severe untreated intrauterine adhesions.
• Endometrial lesions, history of pelvic tumors, or previous radiotherapy or chemotherapy.
• Known allergy to G-CSF.
• Current participation in another clinical study.

Full record on ClinicalTrials.gov

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