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Intrauterine G-CSF Infusion for Thin Endometrium (GIFT)

8 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

620

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Biologique: 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.
Autres noms:
  • Recombinant Human Granulocyte Colony-Stimulating Factor
Comparateur placebo: 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.
Médicament: 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.
Autres noms:
  • Saline

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Live Birth Rate
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Endometrial Thickness
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nanjing University

Collaborateurs

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Les enquêteurs

  • Chercheur principal: Yue Jiang, Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

1 août 2029

Achèvement de l'étude (Estimé)

1 août 2029

Dates d'inscription aux études

Première soumission

4 juillet 2026

Première soumission répondant aux critères de contrôle qualité

8 juillet 2026

Première publication (Réel)

9 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-0087-04

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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