Hyaluronan-EnRiched Medium, Randomized Controlled Trial
Conditions
Brief summary
Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate
Interventions
OTHERuse of hyaluronan-enriched transfer medium
In the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium
Sponsors
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
double blind
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of transfers needed to reach ongoing pregnancy | 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
| Measure | Time frame | Description |
|---|---|---|
| number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy | 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) |
Countries
Belgium
Contacts
CONTACTSophie Debrock, PhD
Outcome results
None listed