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ID
Source
Brief title
Health condition
Embryotransfer Day 3 vs Day 5
In Vitro Fertilization(IVF)
Cumulative live birth rate
Embryotransfer Dag 3 vs Dag 5
In Vitro Fertilisatie(IVF)
Cumulatief aantal levend geborenen
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 zygotes on day 1 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)).
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
Rationale: 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.
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: Multicentre Randomized controlled trial
Study population: Women under 43 years receiving a IVF/ICSI treatment.
Intervention: Blastocyst stage (day 5) embryo transfer
Comparison: Cleavage stage (day 3) embryo transfer
Main study parameters/endpoints: Cumulative live birth rate per started IVF/ICSI cycle, time to pregnancy, costs.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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. Subjects who participate fill in questionnaires at the start and end of the study, as well as on the 4th month after ovum pick-up.
Study objective
The cumulative live birth rate after IVF/ICSI is expected to be 8% higher after blastocyst stage embryo transfers (day 5
compared to cleavage stage embryo transfers (day 3). Furthermore, the time to pregnancy will be shorter and less expensive
IVF/ICSI treatments are necessary.
Study design
The study endpoints for the subject are: after delivery, 12 months after the ovum pick up or when no pregnancy occurs after the IVF treatment cycle.
4 months after the ovum pick-up, a questionnaire concerning the quality of life is send to the subjects.
Intervention
Blastocyst stage (day 5) embryo transfer
Simone Cornelisse
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
The Netherlands
024 361 6644
tof@zorgevaluatienederland.nl
Simone Cornelisse
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
The Netherlands
024 361 6644
tof@zorgevaluatienederland.nl
Inclusion criteria
Women 18-42 years
IVF/ICSI treatment with more than 3 zygotes on culture day 1 available.
Written informed consent
Exclusion criteria
The use of testicular sperm extraction (TESE), Preimplantation genetic diagnosis (PGD)cycles The use of vitrified oocytes -Participating in interfering study.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6857 |
| NTR-old | NTR7034 |
| CCMO | NL64060.000.18 |
| OMON | NL-OMON50232 |