Thin EndometriumPhase 3GIFTNCT07692672
Intrauterine G-CSF Infusion for Thin Endometrium
A Phase 3 study testing Granulocyte Colony-Stimulating Factor(G-CSF) and Normal Saline in people with Thin Endometrium and Female Infertility, run by Nanjing University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Thin Endometrium, Female Infertility
- What is being tested?
- Granulocyte Colony-Stimulating Factor(G-CSF) and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 620 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center Randomized Controlled Trial of Intrauterine G-CSF Infusion for Improving Pregnancy Outcomes in Patients With Thin Endometrium
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.
Read more
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.
Read the detailed description
Thin endometrium remains a clinical challenge in assisted reproductive technology because it may reduce endometrial receptivity and the chance of successful embryo implantation and live birth. Several treatment strategies have been used for thin endometrium, including hormonal treatment, medications to improve blood flow, endometrial stimulation, and intrauterine infusion of granulocyte colony-stimulating factor (G-CSF). However, the clinical benefit of intrauterine G-CSF infusion remains uncertain, partly because previous studies have differed in patient populations, timing of administration, dose, and study design.
This study is designed to evaluate whether intrauterine infusion of G-CSF during the endometrial preparation phase can improve reproductive outcomes in patients with thin endometrium undergoing frozen-thawed embryo transfer. The study uses a prospective, single-center, randomized, parallel-group, blinded, superiority design. Eligible participants will be randomly assigned in a 1:1 ratio to receive either mild endometrial stimulation with intrauterine G-CSF infusion or mild endometrial stimulation with intrauterine normal saline infusion. Randomization will be performed using an interactive web response system.
All participants will receive routine endometrial preparation for frozen-thawed embryo transfer according to local clinical practice. In the intervention group, participants will undergo mild endometrial stimulation followed by intrauterine infusion of G-CSF 300 μg. In the control group, participants will undergo the same mild endometrial stimulation procedure followed by intrauterine infusion of an equal volume of normal saline. Participants, outcome assessors, and statistical analysts will be blinded to group assignment, while the physician performing the intrauterine procedure will not be blinded.
After the intrauterine procedure, endometrial development will be monitored by ultrasound. Embryo transfer will be performed after endometrial transformation according to the frozen-thawed embryo transfer protocol. Participants will be followed for pregnancy outcomes, delivery outcomes, and safety events. The study aims to determine whether the addition of intrauterine G-CSF to mild endometrial stimulation provides a clinically meaningful benefit compared with mild endometrial stimulation and saline control.
- Conditions
- Thin Endometrium, Female Infertility
- Being tested
- Granulocyte Colony-Stimulating Factor(G-CSF), Normal Saline
- Keywords
- Thin Endometrium, G-CSF, Intrauterine Infusion, Frozen-Thawed Embryo Transfer, Live Birth Rate
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Colony-Stimulating Factor(G-CSF)Biological
Also called Recombinant Human Granulocyte Colony-Stimulating Factor
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.
Normal SalineDrug
Also called Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild Endometrial Stimulation With Intrauterine G-CSF Infusion | Experimental | Participants 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. Receives: Biological: Granulocyte Colony-Stimulating Factor(G-CSF) |
| Mild Endometrial Stimulation With Intrauterine Normal Saline Infusion | Placebo comparator | Participants 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From embryo transfer to delivery, approximately 40 weeks after embryo transfer
Secondary outcomes (4)
Endometrial Thickness
Endometrial thickness will be measured by transvaginal ultrasound in the mid-sagittal plane of the uterus as the maximum double-layer endometrial thickness in millimeters.
Measured: On the day 1 of endometrial transformation
Endometrial and Sub-endometrial Blood Flow
Endometrial and sub-endometrial blood flow will be assessed by transvaginal color Doppler or power Doppler ultrasound. Blood flow may be evaluated according to blood flow distribution type and/or three-dimensional Doppler indices, including vascularization index, flow index, and vascularization-flow index.
Measured: On the day 1 of endometrial transformation
Clinical Pregnancy Rate
The proportion of participants with an intrauterine gestational sac confirmed by transvaginal ultrasound after embryo transfer.
Measured: 4 to 6 weeks after embryo transfer
Early Miscarriage Rate
The proportion of participants with clinical pregnancy who experience spontaneous pregnancy loss before 12 weeks of gestation.
Measured: From confirmation of clinical pregnancy to 12 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thin EndometriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either mild endometrial stimulation with intrauterine G-CSF infusion or mild endometrial stimulation with intrauterine normal saline infusion.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Principal investigator, Li-jun Ding, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yue Jiang, Principal investigator, Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692672
- Sponsor's protocol ID
- 2026-0087-04
- Acronym
- GIFT
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31464150Zhu 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.
PubMed 34786386Liu 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.
PubMed 31029557
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Randomized Controlled Trial of Intrauterine G-CSF Infusion for Improving Pregnancy Outcomes in Patients With Thin Endometrium
- ClinicalTrials.gov ID
- NCT07692672
- Acronym / sponsor ID
- GIFT / 2026-0087-04
- Conditions
- Thin Endometrium, Female Infertility
- Keywords
- Thin Endometrium, G-CSF, Intrauterine Infusion, Frozen-Thawed Embryo Transfer, Live Birth Rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thin endometrium remains a clinical challenge in assisted reproductive technology because it may reduce endometrial receptivity and the chance of successful embryo implantation and live birth. Several treatment strategies have been used for thin endometrium, including hormonal treatment, medications to improve blood flow, endometrial stimulation, and intrauterine infusion of granulocyte colony-stimulating factor (G-CSF). However, the clinical benefit of intrauterine G-CSF infusion remains uncertain, partly because previous studies have differed in patient populations, timing of administration, dose, and study design.
This study is designed to evaluate whether intrauterine infusion of G-CSF during the endometrial preparation phase can improve reproductive outcomes in patients with thin endometrium undergoing frozen-thawed embryo transfer. The study uses a prospective, single-center, randomized, parallel-group, blinded, superiority design. Eligible participants will be randomly assigned in a 1:1 ratio to receive either mild endometrial stimulation with intrauterine G-CSF infusion or mild endometrial stimulation with intrauterine normal saline infusion. Randomization will be performed using an interactive web response system.
All participants will receive routine endometrial preparation for frozen-thawed embryo transfer according to local clinical practice. In the intervention group, participants will undergo mild endometrial stimulation followed by intrauterine infusion of G-CSF 300 μg. In the control group, participants will undergo the same mild endometrial stimulation procedure followed by intrauterine infusion of an equal volume of normal saline. Participants, outcome assessors, and statistical analysts will be blinded to group assignment, while the physician performing the intrauterine procedure will not be blinded.
After the intrauterine procedure, endometrial development will be monitored by ultrasound. Embryo transfer will be performed after endometrial transformation according to the frozen-thawed embryo transfer protocol. Participants will be followed for pregnancy outcomes, delivery outcomes, and safety events. The study aims to determine whether the addition of intrauterine G-CSF to mild endometrial stimulation provides a clinically meaningful benefit compared with mild endometrial stimulation and saline control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either mild endometrial stimulation with intrauterine G-CSF infusion or mild endometrial stimulation with intrauterine normal saline infusion.
| Arm | Type | Receives |
|---|---|---|
| Mild Endometrial Stimulation With Intrauterine G-CSF Infusion | Experimental | Biological: Granulocyte Colony-Stimulating Factor(G-CSF)Participants 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 comparator | Drug: Normal SalineParticipants 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte Colony-Stimulating Factor(G-CSF)Also: Recombinant Human Granulocyte Colony-Stimulating FactorParticipants 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. | Biological | Mild Endometrial Stimulation With Intrauterine G-CSF Infusion |
| Normal SalineAlso: SalineParticipants 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. | Drug | Mild Endometrial Stimulation With Intrauterine Normal Saline Infusion |
Primary outcome
Live Birth Rate
Time frame: From embryo transfer to delivery, approximately 40 weeks after embryo transfer
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.
4 secondary outcomes
Endometrial Thickness
Time frame: On the day 1 of endometrial transformation
Endometrial and Sub-endometrial Blood Flow
Time frame: On the day 1 of endometrial transformation
Clinical Pregnancy Rate
Time frame: 4 to 6 weeks after embryo transfer
Early Miscarriage Rate
Time frame: From confirmation of clinical pregnancy to 12 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Results publication: PubMed 31464150Lian 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.
- Results publication: PubMed 34786386Zhu 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.
- Results publication: PubMed 31029557Liu 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yue Jiang principal investigator
Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Granulocyte Colony-Stimulating Factor(G-CSF) and Normal Saline in people with Thin Endometrium and Female Infertility, run by Nanjing University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Jiang, PhD (+8618262637731, jiangyue85@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth Rate (time frame: From embryo transfer to delivery, approximately 40 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07692672, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.