To determine whether blastocyst stage embryo transfers improve the cumulative live birth rate compared with cleavage stageembryo transfers in IVF/ICSI treatments
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim is to study whether blastocyst stage embryo transfers (day 5)
improves the cumulative LBR in IVF/ ICSI
patients with a good prognosis (> 3 embryo's on day 2 after oocyte retrieval).
Secondary outcome
1.) Parameters of IVF treatment: such as live birth rate per first transfer,
time to pregnancy, cumulative live birth rate (> 24 weeks) per started IVF/ICSI
cycle, implantation rate, miscarriage rate.
2.) Parameters of perinatal treatment: i.e. birth defects, perinatal mortality,
preterm birth (< 2,5 kg), high birth weight (> 4kg), small for gestational age
( < 10th percentile or < -2SD), large for gestational age ( > 90th percentile
or > + 2SD), placenta previa, placental abruption, placenta accreta,
pregnancy-induced hypertension, preeclampsia/ HELLP, gestational diabetes
mellitus, placental abruption, preterm rupture of membranes, postpartum
hemorrhage, caesarean section, Apgar < 7 at 5 min, stillbirth per ongoing
pregnancy.
3.) Patient outcome analysis: Quality-Adjusted Life-Years (EuroQol (EQ-5D-5L)
and the Fertility Quality of Life Questionnaire (FertiQoL)),patient preferences.
4.) A cost-effectiveness analysis (CEA) will be performed from a healthcare
perspective. A cost-utility analysis (CUA) will be performed to relate the
burden of intervention to the transfer strategy
Background summary
The last years there is an ongoing debate on which embryo transfer policy in
IVF/ICSI is more effective: blastocyst stage (day 5) or cleavage stage (day 3)
transfer.The cumulative live birth rate(LBR) after IVF/ICSI is expected to be
8% higher after blastocyst stage embryo transfers compared to cleavage stage
embryo transfers. Furthermore, the time to pregnancy will be shorter and less
expensive IVF/ICSI treatments are necessary.
The present RCT will provide evidence which transfer policy leads to the best
outcome in terms of cumulative live birth rate per
started IVF/ ICSI cycle. If blastocyst transfer is equally effective, the time
to pregnancy, as valued by patients, will be shorter.
This would lead to a decrease in burden and could be more effective from a
patient*s viewpoint, but even important to a
decrease in health insurance costs.
Study objective
To determine whether blastocyst stage embryo transfers improve the cumulative
live birth rate compared with cleavage stage
embryo transfers in IVF/ICSI treatments
Study design
Randomized controlled multi-center superiority trial with 12 months of
follow-up
Intervention
Blastocyst stage (day 5) embryo transfer
Study burden and risks
The risk associated with the blastocyst transfer policy is a lower amount of
embryos available for transfer or cryopreservation as some embryos will arrest
in their development in vitro. The potential benefit is a higher chance of
pregnancy and a shorter time to pregnancy with the blastocyst transfer policy,
as valued by patients. There are no extra burdens, efforts or costs to be
expected for the couples.
Geert Grooteplein-Zuid 10
NIJMEGEN 6525 GA
NL
Geert Grooteplein-Zuid 10
NIJMEGEN 6525 GA
NL
Listed location countries
Age
Inclusion criteria
-Women 18-42 years
-IVF/ICSI treatment with at least 4 embryos on culture day 2 available.
-Written informed consent
Exclusion criteria
-Preimplantation genetic diagnosis (PGD)cycles
-The use of vitrified oocytes
-Participating in interfering study
-Patients can only participate one IVF-cycle
-The use of donated oocytes
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64060.000.18 |