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NCT Number: NCT04697823

Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate.

Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate

Recruiting

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Key information

Conditions

Hyaluronan-EnRiched Medium Randomized Controlled Trial

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Leuven University Fertility Center

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Sophie Debrock, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

-

Treatment and study plan

use of hyaluronan-enriched transfer medium

Other

In the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium

Primary outcomes

  1. 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.

Secondary outcomes

  1. number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy

    Time frame: until Live birth: 9 months after ET

    clinical pregnancy is defined as a pregnancy with at least one intrauterine (IU) or extrauterine (EU) fetal sac at 6-7 weeks of pregnancy)

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie Debrock, PhD

CONTACT

[email protected]

0032016340812

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate: a Prospective Randomized Trial

Acronym: TETHER

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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