Intrauterine G-CSF Infusion for Thin Endometrium
GIFT
A Single-Center Randomized Controlled Trial of Intrauterine G-CSF Infusion for Improving Pregnancy Outcomes in Patients With Thin Endometrium
1 other identifier
interventional
620
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2026
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
Study Completion
Last participant's last visit for all outcomes
August 1, 2029
July 9, 2026
July 1, 2026
2.8 years
July 4, 2026
July 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live Birth Rate
The proportion of participants who deliver at least one live-born infant after the registered frozen-thawed embryo transfer cycle. Live birth is defined as delivery of at least one newborn with signs of life at 28 weeks of gestation or later.
From embryo transfer to delivery, approximately 40 weeks after embryo transfer
Secondary Outcomes (4)
Endometrial Thickness
On the day 1 of endometrial transformation
Endometrial and Sub-endometrial Blood Flow
On the day 1 of endometrial transformation
Clinical Pregnancy Rate
4 to 6 weeks after embryo transfer
Early Miscarriage Rate
From confirmation of clinical pregnancy to 12 weeks of gestation
Study Arms (2)
Mild Endometrial Stimulation With Intrauterine G-CSF Infusion
EXPERIMENTALParticipants in this arm will undergo mild endometrial stimulation followed by intrauterine infusion of G-CSF 300 μg during the endometrial preparation cycle for frozen-thawed embryo transfer.
Mild Endometrial Stimulation With Intrauterine Normal Saline Infusion
PLACEBO COMPARATORParticipants in this arm will undergo the same mild endometrial stimulation procedure followed by intrauterine infusion of an equal volume of normal saline during the endometrial preparation cycle for frozen-thawed embryo transfer.
Interventions
Participants in the experimental arm will receive a single intrauterine infusion of G-CSF 300 μg after mild endometrial stimulation during the endometrial preparation cycle for frozen-thawed embryo transfer.
Participants in the control arm will receive a single intrauterine infusion of an equal volume of normal saline after the same mild endometrial stimulation procedure during the endometrial preparation cycle for frozen-thawed embryo transfer.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Lian R, Wang X, Lin R, Zeng H, Zeng Y, Liu S. Evaluation of granulocyte colony-stimulating factor on the treatment of thin endometrium during frozen-thawed embryo transfer cycles: a retrospective cohort study. Gynecol Endocrinol. 2020 Apr;36(4):370-374. doi: 10.1080/09513590.2019.1658187. Epub 2019 Aug 29.
PMID: 31464150RESULTZhu YC, Sun YX, Shen XY, Jiang Y, Liu JY. Effect of intrauterine perfusion of granular leukocyte-colony stimulating factor on the outcome of frozen embryo transfer. World J Clin Cases. 2021 Oct 26;9(30):9038-9049. doi: 10.12998/wjcc.v9.i30.9038.
PMID: 34786386RESULTLiu KE, Hartman M, Hartman A. Management of thin endometrium in assisted reproduction: a clinical practice guideline from the Canadian Fertility and Andrology Society. Reprod Biomed Online. 2019 Jul;39(1):49-62. doi: 10.1016/j.rbmo.2019.02.013. Epub 2019 Mar 20.
PMID: 31029557RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yue Jiang
Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants, outcome assessors, and statistical analysts will be blinded to group assignment. The intrauterine procedure will be performed in the same manner in both groups, and participants will not be informed whether they receive G-CSF or normal saline. Outcome assessors will not participate in randomization or the intrauterine procedure, and ultrasound and clinical outcome data will be assessed using anonymized identifiers. Statistical analysts will receive coded group information as Group A and Group B. The physician performing the intrauterine procedure will not be blinded because they must prepare and administer the assigned infusion.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
July 4, 2026
First Posted
July 9, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
August 1, 2029
Last Updated
July 9, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared because the study involves sensitive reproductive, pregnancy, delivery, and neonatal clinical information. The current study protocol and informed consent documents do not include a plan for public sharing of individual participant data. De-identified aggregate data may be reported in scientific publications.