Actively Recruiting
Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate: a Prospective Randomized Trial
Led by KU Leuven · Updated on 2026-03-30
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether using a hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate in women undergoing embryo transfer. This prospective randomized trial compares the effects of this enriched medium to the conventional culture medium in patients planning multiple oocyte retrievals but with no ongoing clinical pregnancy from previous attempts. The study is sponsored by KU Leuven and aims to better understand how the transfer medium influences pregnancy success. Participants are randomly assigned to one of two groups: one group receives embryo transfer using the hyaluronan-enriched medium, while the control group receives embryo transfer with the standard culture medium. The study follows a double-blind design to ensure unbiased results. The primary outcome is the number of transfers needed to reach an ongoing pregnancy, defined by a viable fetus with fetal heartbeat at 12 weeks. Secondary outcomes include transfers needed to reach clinical pregnancy, live birth, miscarriage, and multiple pregnancy. Participants will be monitored through their embryo transfer cycles until an ongoing pregnancy or live birth occurs. Researchers will track pregnancy status, including fetal heartbeat and clinical outcomes up to nine months after embryo transfer. Women aged 18 to 40 with their own oocytes or embryos, and a BMI of 32 or less, who have had no ongoing pregnancy after previous retrievals, are eligible. The study includes informed consent and follows participants until the measured outcomes are achieved or the study ends.
CONDITIONS
Brief Title
Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with own oocytes or embryos
- Female age younger than 40 years at first or current oocyte retrieval
- Patients planned for a second oocyte retrieval with no clinical ongoing pregnancy after the previous retrieval
- Patients planned for a third oocyte retrieval with no clinical ongoing pregnancy after previous retrievals
- Patients with BMI of 32 or less
- Patients who have provided written informed consent
You will not qualify if you...
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until ongoing pregnancy is achieved or treatment is discontinued
Participants undergo embryo transfer using either hyaluronan-enriched transfer medium or conventional culture medium as part of the study intervention.
Number of embryo transfers depends on individual treatment response
Trial Site Locations
Total: 1 location
1
Leuven University Fertility Center
Leuven, Belgium, 3000
Actively Recruiting
Research Team
S
Sophie Debrock, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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