Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

November 28, 2025 updated by: He Cai, Northwest Women's and Children's Hospital, Xi'an, Shaanxi

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
858

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710003
        • Recruiting
        • IVF laboratory
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hyaluronic Acid(EmbryoGlue®)
High HA concentrations (0.5 mg/ml)
Biological: High Hyaluronic Acid concentrations (0.5 mg/ml)
Hyaluronic Acid(EmbryoGlue®)
Active Comparator: Hyaluronic Acid (G2 medium)
Low HA concentrations (0.125 mg/ml)
Biological: Low Hyaluronic Acid concentrations (0.125 mg/ml)
Hyaluronic Acid (G2 medium)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Live birth is defined as the birth of at least one live baby after 24 weeks of gestation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
low birth weight
Time Frame: At birth
Weight of baby born < 2500 g
At birth
Very low birth weight
Time Frame: At birth
Weight of baby born < 1500 g
At birth
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.
12 days after embryo transfer.
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).
6-8 weeks after embryo transfer
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.
after 12 weeks of gestation.
Miscarriage
Time Frame: 20 weeks of gestation.
Miscarriage is defined as spontaneous loss of an intrauterine pregnancy before 20 completed weeks of gestation.
20 weeks of gestation.
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.
After 4 to 6 weeks of embryo transfer
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 weeks of gestation.
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.
From 20 weeks of gestation up to at birth
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
From 20 weeks of gestation up to at birth
Preterm birth
Time Frame: At birth
Delivery of a fetus at less than 37 and more than 28 weeks gestational age
At birth
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
Before 37 weeks of gestation and before the onset of labor
Mode of delivery
Time Frame: At birth
Vaginal delivery or cesarean delivery
At birth
Gestational age
Time Frame: At birth
Gestational age recorded at delivery
At birth
Birth weight
Time Frame: At birth
Weight of baby born (grams)
At birth
Mean birth weight
Time Frame: 1 year after embryo transfer
By checking medical records
1 year after embryo transfer
Macrosomia
Time Frame: At birth
Weight of baby born > 4000 g
At birth
Large for gestational age
Time Frame: At birth
Birthweight > 90th percentile
At birth
Small for gestational age
Time Frame: At birth
Birthweight < 10th percentile
At birth
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
Birth up to 1 year
Stillbirth or late fetal death
Time Frame: At birth
Fetal death at 20 or more weeks' gestation
At birth
Early neonatal death
Time Frame: Up to 28 days after birth
Up to 28 days after birth
Congenital anomaly or birth defect
Time Frame: Birth to first year of life
Any congenital anomalies detected in baby born
Birth to first year of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwest Women's and Children's Hospital, Xi'an, Shaanxi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Huazhong University of Science and Technology
Jiangxi Maternal and Child Health Hospital
Gansu Provincial Maternal and Child Health Care Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Juanzi Shi, Doctor, Center for Reproductive Medicine, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-127

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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