Hyaluronic Acid-enriched Transfer Medium in Single Blastocyst Transfer

NCT06492785 | Recruiting DMC

• 1 other identifier: 2024-127
• Study Type: interventional
• Target: 858
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Keywords

Hyaluronate-enriched medium; live birth; Single blastocyst transfer

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  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 Outcomes (23)

• Biochemical pregnancy

  12 days after embryo transfer.

• Clinical pregnancy

  6-8 weeks after embryo transfer

• Ongoing pregnancy

  after 12 weeks of gestation.

• Miscarriage

  20 weeks of gestation.

• Ectopic pregnancy

  After 4 to 6 weeks of embryo transfer

Study Arms (2)

Hyaluronic Acid(EmbryoGlue®)

EXPERIMENTAL

High HA concentrations (0.5 mg/ml)

Biological: High Hyaluronic Acid concentrations (0.5 mg/ml)

Hyaluronic Acid (G2 medium)

ACTIVE COMPARATOR

Low HA concentrations (0.125 mg/ml)

Biological: Low Hyaluronic Acid concentrations (0.125 mg/ml)

Interventions

Low Hyaluronic Acid concentrations (0.125 mg/ml) BIOLOGICAL

Hyaluronic Acid (G2 medium)

Hyaluronic Acid (G2 medium)

High Hyaluronic Acid concentrations (0.5 mg/ml) BIOLOGICAL

Hyaluronic Acid(EmbryoGlue®)

Hyaluronic Acid(EmbryoGlue®)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jiangxi Maternal and Child Health Hospital: collaborator
• Huazhong University of Science and Technology: collaborator
• Northwest Women's and Children's Hospital, Xi'an, Shaanxi: lead
• Gansu Provincial Maternal and Child Health Care Hospital: collaborator

Study Sites (1)

IVF laboratory

Xi'an, Shaanxi, 710003, China

RECRUITING

Related Publications (1)

• Cai H, Xu D, Wang Z, Huang B, Xue X, Bai H, Man Y, Lei D, Wu Q, Ni Y, Lei J, Shi J. Efficacy and safety of hyaluronic acid-enriched transfer medium in women undergoing single blastocyst transfer: a study protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Nov 19;15(11):e104571. doi: 10.1136/bmjopen-2025-104571.

  PMID: 41263844 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Juanzi Shi, Doctor

  Center for Reproductive Medicine, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, China

  STUDY CHAIR

Central Study Contacts

He Cai, Doctor

CONTACT

13581613908; caihe@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: September 13, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (1)