NCT02725827

Brief Summary

This is a randomized-controlled trial evaluating the effect of the use of hyaluronan (HA)-enriched embryo transfer medium on the live birth rate in women undergoing frozen-thawed embryo transfer. For half of the women, hyaluronan-enriched medium will be used as embryo transfer medium. For the other half of women, a control will be used.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

March 23, 2016

Last Update Submit

January 23, 2019

Conditions

In Vitro FertilizationSubfertility

Outcome Measures

Primary Outcomes (1)

  • Live-birth rate per embryo transfer procedure

    1 year

Secondary Outcomes (6)

  • pregnancy rate

    4 weeks

  • clinical pregnancy rate

    4 weeks

  • implantation rate

    8 weeks

  • on-going pregnancy rate

    8 weeks

  • adverse events

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

HA group

ACTIVE COMPARATOR

One the day of frozen-thawed embryo transfer, frozen embryos will be thawed and incubated for at least 10 minutes in embryo transfer medium. For women allocated to the HA group, EmbryoGlue (Vitrolife), a hyaluronan-enriched embryo transfer medium, will be used as embryo transfer medium. EmbryoGlue contains a higher concentration of hyaluronan than the control medium.

Other: EmbryoGlue (Vitrolife)

Control group

ACTIVE COMPARATOR

For women allocated to the control group, the usual transfer medium used in the study centers will be used and will serve as control. The main difference between the two media is that EmbryoGlue contains a higher concentration of HA.

Other: Control medium

Interventions

EmbryoGlue (Vitrolife)OTHER

A hyaluronan-enriched embryo transfer medium

HA group
Control mediumOTHER

The usual embryo transfer medium used in the study centres.

Control group

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women panning to replacing early cleavage embryos or blastocysts after thawing.

You may not qualify if:

  • Frozen early cleavage embryos thawed and cultured to blastocysts prior to transfer as requested by the patient
  • Preimplantation genetic diagnosis treatment
  • Use of donor oocytes or donor embryos
  • Endometrial thickness \<8mm on the day of the luteinizing hormone surge or after two weeks of estrogen in hormonal replacement cycles
  • Hydrosalpinx shown on pelvic scanning and not surgically treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital, University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Yung SSF, Lai SF, Lam MT, Lui EMW, Ko JKY, Li HWR, Wong JYY, Lau EYL, Yeung WSB, Ng EHY. Hyaluronic acid-enriched transfer medium for frozen embryo transfer: a randomized, double-blind, controlled trial. Fertil Steril. 2021 Oct;116(4):1001-1009. doi: 10.1016/j.fertnstert.2021.02.015. Epub 2021 Apr 9.

    PMID: 33845988DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Shuk Fei Sofie Yung, MBBS

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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
Clinical Assistant Professor

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 1, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

HK(2)