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NCT Number: NCT06492785

Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

The purpose of this study is to compare the live birth rates of high concentration of Hyaluronic Acid (0.5 mg/ml) transfer medium (EmbryoGlue®) to those containing low Hyaluronic Acid concentrations (0.125 mg/ml) (G2 medium) in women undergoing single fresh and frozen blastocyst transfer.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The single blastocyst-stage embryo transfer cycles will be randomised in a 1:1 allocation, with block sizes of 2 and 4 on the day of Embryo Transfer (ET). This randomisation process will be centrally managed via a web-based electronic data capture system and will be stratified according to the treatment center. The allocation sequence and the designated treatment will be completely concealed from the participating couples, clinicians - including those conducting the transfer procedures - and outcome assessors. Given the intrinsic viscous nature of EmbryoGlue, embryologists, who who are responsible for the procedures in the laboratory will not be subjected to blinding. Only at the end of the study, when data collection is completed, the allocation sequence will be revealed to the primary investigators.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All cycles with single blastocyst transfer will be considered eligible
  • Both fresh and cryopreserved embryo transfer cycles utilizing autologous oocytes
  • No age restriction will be applied
  • Informed consent was signed

Exclusion criteria

  • Uterine anatomic anomalies
  • Women with untreated hydrosalpines
  • Once couples have been enrolled in the trial, subsequent cycles will not be incorporated.

Treatment and study plan

High Hyaluronic Acid concentrations (0.5 mg/ml)

Biological

Hyaluronic Acid(EmbryoGlue®)

Low Hyaluronic Acid concentrations (0.125 mg/ml)

Biological

Hyaluronic Acid (G2 medium)

Primary outcomes

  1. Live birth rate

    Time frame: Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.

    The primary outcome was Live birth rate per embryo transfer.

Secondary outcomes

  1. Biochemical pregnancy

    Time frame: 12 days after embryo transfer.

    Biochemical pregnancy is defined as serum beta-human chorionic gonadotropin β-hCG > 20 IU/L 12 days after embryo transfer.

  2. Clinical pregnancy

    Time frame: 6-8 weeks after embryo transfer

    Clinical pregnancy is defined as the presence of at least one gestational sac confirmed by ultrasonography (ectopic pregnancy is included as a clinical pregnancy).

  3. Ongoing pregnancy

    Time frame: after 12 weeks of gestation.

    Ongoing pregnancy is defined as the presence of a gestational sac and fetal heartbeat after 12 weeks of gestation.

  4. Miscarriage

    Time frame: 20 weeks of gestation.

    Miscarriage is defined as spontaneous loss of an intrauterine pregnancy before 20 completed weeks of gestation.

  5. Ectopic pregnancy

    Time frame: After 4 to 6 weeks of embryo transfer

    Ectopic pregnancy is defined as a pregnancy implanted outside the uterine cavity, diagnosed by ultrasonography, surgical visualization, or histopathology.

  6. Multiple pregnancy

    Time frame: 7 weeks of gestation.

    Multiple pregnancy is defined as a pregnancy with two or more gestational sacs or fetal heartbeats at 7 weeks of gestation.

  7. hypertensive disorders in pregnancy

    Time frame: From 20 weeks of gestation up to at birth

    Comprising essential hypertension; pregnancy induced hypertension; pre-eclampsia and eclampsia.

  8. Placental implantation disorders

    Time frame: From 20 weeks of gestation up to at birth

    Placental implantation disorders encompass placenta previa, placenta accreta spectrum, placental abruption and/or abnormal cord insertion

  9. Preterm birth

    Time frame: At birth

    Delivery of a fetus at less than 37 and more than 28 weeks gestational age

  10. Preterm premature rupture of membranes

    Time frame: Before 37 weeks of gestation and before the onset of labor

    Preterm premature rupture of membranes is defined as the leakage of amniotic fluid through the cervical os before 37 weeks of gestation and before the onset of labor

  11. Mode of delivery

    Time frame: At birth

    Vaginal delivery or cesarean delivery

  12. Gestational age

    Time frame: At birth

    Gestational age recorded at delivery

  13. Birth weight

    Time frame: At birth

    Weight of baby born (grams)

  14. low birth weight

    Time frame: At birth

    Weight of baby born < 2500 g

  15. Very low birth weight

    Time frame: At birth

    Weight of baby born < 1500 g

  16. Mean birth weight

    Time frame: 1 year after embryo transfer

    By checking medical records

  17. Macrosomia

    Time frame: At birth

    Weight of baby born > 4000 g

  18. Large for gestational age

    Time frame: At birth

    Birthweight > 90th percentile

  19. Small for gestational age

    Time frame: At birth

    Birthweight < 10th percentile

  20. Neonatal intensive care unit admission

    Time frame: Birth up to 1 year

    Safety outcome. Number of pregnancies for which newborn is admitted to the NICU

  21. Stillbirth or late fetal death

    Time frame: At birth

    Fetal death at 20 or more weeks' gestation

  22. Early neonatal death

    Time frame: Up to 28 days after birth

  23. Congenital anomaly or birth defect

    Time frame: Birth to first year of life

    Any congenital anomalies detected in baby born

Study contacts

Contact information is provided by the study sponsor or research team.

He Cai, Doctor

CONTACT

[email protected]

13581613908

Sponsors and collaborators

Lead sponsor

Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Other

Collaborators

  • Gansu Provincial Maternal and Child Health Care Hospital
  • Huazhong University of Science and Technology
  • Jiangxi Maternal and Child Health Hospital

Registry information

Official study title

Use of Hyaluronic Acid-enriched Transfer Medium in Women Undergoing Single Blastocyst Transfer : a Multicenter, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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