Hyaluronan-EnRiched MediumTETHERNCT04697823
Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate.
A study testing use of hyaluronan-enriched transfer medium in people with Hyaluronan-EnRiched Medium and Randomized Controlled Trial, run by KU Leuven at 1 site in Belgium.
Trial summary
Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyaluronan-EnRiched Medium, Randomized Controlled Trial
- What is being tested?
- use of hyaluronan-enriched transfer medium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with own oocytes/embryos;
- Patients with female age at 1st OR in the study <40 year;
- Patients planned for a 2nd oocyte retrieval, with no clinical ongoing pregnancy after the previous oocyte retrieval
- Patients planned for a 3rd oocyte retrieval with no clinical ongoing pregnancy after previous oocyte retrievals
- Patients with female age at 1st OR in the study <40 year;
- Patients with BMI ≤32;
- Patients with written informed consent;
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Leuven University Fertility Center
Leuven, 3000
Sophie Debrock, PhD
About this study
Official title: Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate: a Prospective Randomized Trial
Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate
- Being tested
- use of hyaluronan-enriched transfer medium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of hyaluronan-enriched transfer mediumOther
In the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | Patients receiving an embryo transfer in hyaluronan-enriched transfer medium Receives: Other: use of hyaluronan-enriched transfer medium |
| control group | No intervention | Patients receiving an embryo transfer in conventional culture medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of transfers needed to reach ongoing pregnancy
The primary outcome parameter is the number of transfers needed to reach ongoing pregnancy (ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy), as a time-to-event outcome variable. Patients that do not reach pregnancy, are censored at their last transfer.
Measured: ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy
Secondary outcomes (1)
number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy
clinical pregnancy is defined as a pregnancy with at least one intrauterine (IU) or extrauterine (EU) fetal sac at 6-7 weeks of pregnancy)
Measured: until Live birth: 9 months after ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyaluronan-EnRiched MediumStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Debrock, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697823
- Sponsor's protocol ID
- S64387
- Acronym
- TETHER
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2020
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04697823
- Acronym / sponsor ID
- TETHER / S64387
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jan 2021 (actual)
- 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.
Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Other: use of hyaluronan-enriched transfer mediumPatients receiving an embryo transfer in hyaluronan-enriched transfer medium |
| control group | No intervention | –Patients receiving an embryo transfer in conventional culture medium |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with own oocytes/embryos;
- Patients with female age at 1st OR in the study <40 year;
- Patients planned for a 2nd oocyte retrieval, with no clinical ongoing pregnancy after the previous oocyte retrieval
- Patients planned for a 3rd oocyte retrieval with no clinical ongoing pregnancy after previous oocyte retrievals
- Patients with female age at 1st OR in the study <40 year;
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| use of hyaluronan-enriched transfer mediumIn the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium | Other | study group |
Primary outcome
number of transfers needed to reach ongoing pregnancy
Time frame: ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy
The primary outcome parameter is the number of transfers needed to reach ongoing pregnancy (ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy), as a time-to-event outcome variable. Patients that do not reach pregnancy, are censored at their last transfer.
1 secondary outcome
number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy
Time frame: until Live birth: 9 months after ET
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of hyaluronan-enriched transfer medium in people with Hyaluronan-EnRiched Medium and Randomized Controlled Trial, run by KU Leuven at 1 site in Belgium.
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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Debrock, PhD (0032016340812, sophie.debrock@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of transfers needed to reach ongoing pregnancy (time frame: ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.