Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorKU Leuven
About this trial
Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
use of hyaluronan-enriched transfer medium
Other interventionIn the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: study groupActive comparator 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancySecondary 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)
Time frame
until Live birth: 9 months after ET Source ClinicalTrials.gov