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Intrauterine G-CSF Infusion for Thin Endometrium (GIFT)

8. juli 2026 opdateret af: Li-jun Ding, Nanjing University

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.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

620

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mild Endometrial Stimulation With Intrauterine G-CSF Infusion
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.
Biologisk: 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.
Andre navne:
  • Recombinant Human Granulocyte Colony-Stimulating Factor
Placebo komparator: Mild Endometrial Stimulation With Intrauterine Normal Saline Infusion
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.
Medicin: 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.
Andre navne:
  • Saltvand

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Live Birth Rate
Tidsramme: 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.
From embryo transfer to delivery, approximately 40 weeks after embryo transfer

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endometrial Thickness
Tidsramme: On the day 1 of endometrial transformation
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.
On the day 1 of endometrial transformation
Endometrial and Sub-endometrial Blood Flow
Tidsramme: On the day 1 of endometrial transformation
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.
On the day 1 of endometrial transformation
Clinical Pregnancy Rate
Tidsramme: 4 to 6 weeks after embryo transfer
The proportion of participants with an intrauterine gestational sac confirmed by transvaginal ultrasound after embryo transfer.
4 to 6 weeks after embryo transfer
Early Miscarriage Rate
Tidsramme: From confirmation of clinical pregnancy to 12 weeks of gestation
The proportion of participants with clinical pregnancy who experience spontaneous pregnancy loss before 12 weeks of gestation.
From confirmation of clinical pregnancy to 12 weeks of gestation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanjing University

Samarbejdspartnere

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Efterforskere

  • Ledende efterforsker: Yue Jiang, Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. august 2029

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

4. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-0087-04

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Granulocyte Colony-Stimulating Factor(G-CSF)

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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