Health TrialsbyHealthPanel

Intrauterine G-CSF Infusion for Thin Endometrium

ConditionsThin EndometriumFemale Infertility
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorNanjing University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Granulocyte Colony-Stimulating Factor(G-CSF)

    Biological/Vaccine

    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 Saline

    Drug

    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.

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: Mild Endometrial Stimulation With Intrauterine G-CSF InfusionExperimental treatment 1 intervention
Group B: Mild Endometrial Stimulation With Intrauterine Normal Saline InfusionPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
From embryo transfer to delivery, approximately 40 weeks after embryo transfer

Secondary outcomes

1

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.

Time frame
On the day 1 of endometrial transformation
2

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.

Time frame
On the day 1 of endometrial transformation
3

Clinical Pregnancy Rate

The proportion of participants with an intrauterine gestational sac confirmed by transvaginal ultrasound after embryo transfer.

Time frame
4 to 6 weeks after embryo transfer
4

Early Miscarriage Rate

The proportion of participants with clinical pregnancy who experience spontaneous pregnancy loss before 12 weeks of gestation.

Time frame
From confirmation of clinical pregnancy to 12 weeks of gestation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing University

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor institution

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: