In Vitro FertilizationNCT02725827
Hyaluronan-enriched Embryo Transfer Medium for Frozen-thawed Embryo Transfer
A study testing EmbryoGlue (Vitrolife) in people with In Vitro Fertilization and Subfertility, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- In Vitro Fertilization, Subfertility
- What is being tested?
- EmbryoGlue (Vitrolife)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 2 sitesHong Kong
- Study dates
- Apr 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women panning to replacing early cleavage embryos or blastocysts after thawing.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Kwong Wah Hospital
Hong Kong
Queen Mary Hospital, University of Hong Kong
Hong Kong
About this study
Official title: Randomized Controlled Trial Comparing Hyaluronan-enriched Embryo Transfer Medium Versus Control for Frozen-thawed Embryo Transfer
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.
Read the detailed description
Women being scheduled for FET will be assessed for eligibility. Eligible women will be recruited for the study and each woman will only be included in the study with one FET cycle. Informed written consent will be obtained. Their baseline characteristics will be collected.
Women with regular ovulatory cycles will undergo the standard procedures of blood taking to identify the day of luteinizing hormone (LH) surge. Women with irregular cycles will either receive clomiphene or letrozole followed by detection of the LH surge, or undergo hormone replacement therapy (HRT) cycle with oral oestradiol 6 mg daily for 14 days for endometrial priming followed by the addition of vaginal micronized progesterone 100 mg three times daily. HRT cycle may also be used for scheduling purposes.
Embryo transfer will be performed 3 or 4 days (for cleavage-stage embryos) or 6 or 7 days (for blastocysts) after the LH surge. For women in HRT cycles, FET will be scheduled on the 4th or 5th day (for cleavage-stage embryos) or the 7th or 8th day (for blastocysts) of starting vaginal progesterone. They will continue oral oestradiol and vaginal progesterone after FET up to 12 weeks of gestation.
Randomization:
One day before scheduled FET, recruited women will be randomized into one of the following two groups: (1) HA group and (2) control group according to a computer-generated randomization list prepared by a designated research nurse.
One the day of FET, frozen embryos or blastocysts will be thawed and incubated for at least 10 minutes in embryo transfer medium. For women allocated to the HA group, EmbryoGlue (Vitrolife) will be used as embryo transfer medium, while in the control group the usual medium used in the study center will used. The main difference between the two media is that EmbryoGlue contains a higher concentration of HA.
The rest of the embryo transfer procedure will be the same as the usual practice.
Blinding:
The patient and the physicians performing the FET and involved in her care will not know the group allocation. Only the embryologist will know the group allocation, but they will not be involved in the patient care, the FET procedure and subsequent assessment.
Follow-up and data collection:
A urine pregnancy test is performed 18 days after the LH surge or starting vaginal progesterone. If the pregnancy test is positive, transvaginal ultrasound will be performed 2 weeks later to locate the pregnancy and fetal viability. Subsequent management will be the same as other women with early pregnancy. They will be referred for antenatal care when the pregnancy is on-going at 8 weeks.
Follow-up:
Written consent regarding retrieval of pregnancy and delivery data from both public and private sectors will be sought from the patient at the time of study. The obstetric outcomes will be traced from the electric patient record system if the patients deliver in Hospital Authority hospitals. A pre-formatted letter with replying address available will be given to the patient at the end of the study period and is to be filled by the private obstetrician and returned to us after delivery. If no reply letter is received 2-3 months after the expected date of confinement of the patient, a letter including patient's authorization will be sent to the corresponding private obstetrician to retrieve the information of the pregnancy outcomes. The outcome of the pregnancy (delivery, miscarriage), number of babies born, birth weights and obstetrics complications will be recorded.
- Conditions
- In Vitro Fertilization, Subfertility
- Being tested
- EmbryoGlue (Vitrolife), Control medium
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbryoGlue (Vitrolife)Other
A hyaluronan-enriched embryo transfer medium
Control mediumOther
The usual embryo transfer medium used in the study centres.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live-birth rate per embryo transfer procedure
Measured: 1 year
Secondary outcomes (6)
pregnancy rate
positive urine pregnancy test
Measured: 4 weeks
clinical pregnancy rate
presence of intrauterine gestational sac on ultrasound
Measured: 4 weeks
implantation rate
number of gestational sacs per embryo transferred
Measured: 8 weeks
on-going pregnancy rate
viable pregnancy beyond gestation 8 weeks
Measured: 8 weeks
adverse events
Measured: 12 weeks
obstetric complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Kwong Wah Hospital
- Responsible party
- Principal investigator, Dr. YUNG Shuk Fei Sofie, The University of Hong Kong
- Investigators
- Shuk Fei Sofie Yung, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725827
- Sponsor's protocol ID
- UW 16-158
- Status last verified
- Jan 2019
- First submitted
- 23 Mar 2016
- Last updated
- 25 Jan 2019
- Results posted
- No
Publications
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.
PubMed 33845988
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Hyaluronan-enriched Embryo Transfer Medium Versus Control for Frozen-thawed Embryo Transfer
- ClinicalTrials.gov ID
- NCT02725827
- Acronym / sponsor ID
- UW 16-158
- Conditions
- In Vitro Fertilization, Subfertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Kwong Wah Hospital
- Study start
- Apr 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Women being scheduled for FET will be assessed for eligibility. Eligible women will be recruited for the study and each woman will only be included in the study with one FET cycle. Informed written consent will be obtained. Their baseline characteristics will be collected.
Women with regular ovulatory cycles will undergo the standard procedures of blood taking to identify the day of luteinizing hormone (LH) surge. Women with irregular cycles will either receive clomiphene or letrozole followed by detection of the LH surge, or undergo hormone replacement therapy (HRT) cycle with oral oestradiol 6 mg daily for 14 days for endometrial priming followed by the addition of vaginal micronized progesterone 100 mg three times daily. HRT cycle may also be used for scheduling purposes.
Embryo transfer will be performed 3 or 4 days (for cleavage-stage embryos) or 6 or 7 days (for blastocysts) after the LH surge. For women in HRT cycles, FET will be scheduled on the 4th or 5th day (for cleavage-stage embryos) or the 7th or 8th day (for blastocysts) of starting vaginal progesterone. They will continue oral oestradiol and vaginal progesterone after FET up to 12 weeks of gestation.
Randomization:
One day before scheduled FET, recruited women will be randomized into one of the following two groups: (1) HA group and (2) control group according to a computer-generated randomization list prepared by a designated research nurse.
One the day of FET, frozen embryos or blastocysts will be thawed and incubated for at least 10 minutes in embryo transfer medium. For women allocated to the HA group, EmbryoGlue (Vitrolife) will be used as embryo transfer medium, while in the control group the usual medium used in the study center will used. The main difference between the two media is that EmbryoGlue contains a higher concentration of HA.
The rest of the embryo transfer procedure will be the same as the usual practice.
Blinding:
The patient and the physicians performing the FET and involved in her care will not know the group allocation. Only the embryologist will know the group allocation, but they will not be involved in the patient care, the FET procedure and subsequent assessment.
Follow-up and data collection:
A urine pregnancy test is performed 18 days after the LH surge or starting vaginal progesterone. If the pregnancy test is positive, transvaginal ultrasound will be performed 2 weeks later to locate the pregnancy and fetal viability. Subsequent management will be the same as other women with early pregnancy. They will be referred for antenatal care when the pregnancy is on-going at 8 weeks.
Follow-up:
Written consent regarding retrieval of pregnancy and delivery data from both public and private sectors will be sought from the patient at the time of study. The obstetric outcomes will be traced from the electric patient record system if the patients deliver in Hospital Authority hospitals. A pre-formatted letter with replying address available will be given to the patient at the end of the study period and is to be filled by the private obstetrician and returned to us after delivery. If no reply letter is received 2-3 months after the expected date of confinement of the patient, a letter including patient's authorization will be sent to the corresponding private obstetrician to retrieve the information of the pregnancy outcomes. The outcome of the pregnancy (delivery, miscarriage), number of babies born, birth weights and obstetrics complications will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA group | Active comparator | Other: EmbryoGlue (Vitrolife)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. |
| Control group | Active comparator | Other: Control mediumFor 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women panning to replacing early cleavage embryos or blastocysts after thawing.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbryoGlue (Vitrolife)A hyaluronan-enriched embryo transfer medium | Other | HA group |
| Control mediumThe usual embryo transfer medium used in the study centres. | Other | Control group |
Primary outcome
Live-birth rate per embryo transfer procedure
Time frame: 1 year
6 secondary outcomes
pregnancy rate
Time frame: 4 weeks
clinical pregnancy rate
Time frame: 4 weeks
implantation rate
Time frame: 8 weeks
on-going pregnancy rate
Time frame: 8 weeks
adverse events
Time frame: 12 weeks
obstetric complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Derived from this study: PubMed 33845988Yung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuk Fei Sofie Yung, MBBS principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmbryoGlue (Vitrolife) in people with In Vitro Fertilization and Subfertility, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live-birth rate per embryo transfer procedure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019; AzTrials last refreshed its copy on 1 Nov 2026.