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Intrauterine G-CSF Infusion for Thin Endometrium

NCT07692672 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2026-07-09

No results posted yet for this study

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.

Conditions

  • Thin Endometrium
  • Female Infertility

Interventions

BIOLOGICAL

Granulocyte Colony-Stimulating Factor(G-CSF)

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.

DRUG

Normal 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.

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Nanjing University

    lead OTHER

Principal Investigators

  • Yue Jiang · Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-08-31
Completion
2029-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07692672 on ClinicalTrials.gov