|- candidate number||28612|
|- NTR Number||NTR7034|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-feb-2018|
|- Secondary IDs||NL64060.000.18 CCMO Den Haag|
|- Public Title||ToF-studie
Embryo transfer, day Three Or day Five, in good prognosis IVF cycles.|
|- Scientific Title||Cumulative live birth rate after cleavage-stage(day three) or blastocyst(day five) stage embryo transfer in good prognosis IVF/ICSI cycles|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||IVF, Embryotransfer|
|- 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.|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2018|
|- planned closingdate||1-apr-2022|
|- Target number of participants||1200|
|- Interventions|| Blastocyst stage (day 5) embryo transfer |
|- 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
|- Timepoints||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.
|- Trial web site||https://zorgevaluatienederland.nl/tof|
|- CONTACT FOR PUBLIC QUERIES|| Simone Cornelisse|
|- CONTACT for SCIENTIFIC QUERIES|| Simone Cornelisse|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Leading the Change, ZonMw|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||19-feb-2018 - 11-mrt-2018|