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ENDO-RECEPT

 

Disengagement of embryo transfer from ovarian hyperstimulation in IVF / ICSI treatment:  A single-center non-blinded randomized controlled trial

 

Background
Embryo implantation rates in IVF/ICSI treatments are still disappointingly low and only 20% of couples undergoing IVF/ICSI conceives. IVF/ICSI cycles start with ovarian hyperstimulation to obtain multiple oocytes for in vitro fertilization. Ovarian hyperstimulation does not only lead to the maturation of multiple oocytes but also causes changes in the endometrium that may hamper endometrial receptivity and thereby creating suboptimal implantation chances for the transferred embryo. We aim to improve the ongoing pregnancy rates in IVF/ICSI cycles by disengagement of ovarian hyperstimulation and embryo transfer.

 

Objective
To compare the cumulative ongoing pregnancy rate after transfer of frozen-thawed embryos in cycles without ovarian hyperstimulation (disengagement strategy) versus transfer of fresh embryos in cycles with ovarian hyperstimulation (standard strategy).

 

Study design
A randomized clinical trial, non-blinded.

 

Study population
Subfertile couples undergoing their first IVF or ICSI cycle with female age between 18 and 43.

 

Intervention
Patients will be randomly allocated to the intervention arm with cryopreservation of all embryos and transfer of frozen-thawed embryos in cycles without ovarian hyperstimulation (disengagement strategy) or to the control arm with transfer of fresh embryos in cycles with ovarian hyperstimulation (standard strategy).

 

Outcome measures
Primary outcome measure: ongoing pregnancy rate.
Secondary outcome measures: embryo quality, implantation rate, biochemical pregnancy, clinical pregnancy, time to pregnancy, multiple pregnancies, fetal growth, pregnancy complications, live birth, health of babies born, quality of life and costs.

 

Power/data analysis
We expect an increase in ongoing pregnancy rate from 20% to 40% (intention to treat analysis). With an alpha error rate of 5% and beta error rate of 20% (i.e. 80% power), 100 women will need to be randomized to the intervention arm, and 100 women to the control arm (200 in total). This number includes a dropout rate of 15%.

 

Time schedule
12 months of inclusions
12 months of follow up


Subsidy
ZonMw

 

Contact (researcher)
Drs. K.M. Wong, PhD student
Academic Medical Center
Q3-119, Meibergdreef 9, 1105 AZ Amsterdam
Endorecept@amc.uva.nl