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

May 23, 2023 updated by: Sophie Debrock, KU Leuven

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Leuven University Fertility Center
        • Contact:
          • Sophie Debrock, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study group
Patients receiving an embryo transfer in hyaluronan-enriched transfer medium
Other: use of hyaluronan-enriched transfer medium
In the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium
No Intervention: control group
Patients receiving an embryo transfer in conventional culture medium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
until Live birth: 9 months after ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S64387

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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