Abstract
BackgroundFrozen thawed embryo transfer (FET) is a cost- effective adjunct to IVF or IVF-ICSI treatment. In order to optimize treatment outcome, FET should be carried out during a period of optimal endometrial receptivity. To optimize implantation several methods for endometrium preparation have been proposed. In natural cycle FET (NC-FET), the endometrium develops under endogenous hormonal stimulation. The development of the dominant follicle and endometrium is monitored by ultrasound and FET is timed after triggering ovulation induction or determination of the spontaneous LH surge. In an artificial cycle FET (AC-FET) estrogens and progesterone are administered to prepare the endometrium for implantation. While the currently available data show no significant difference in pregnancy rates between these methods, well designed randomized controlled trials are lacking. Moreover there is little literature on difference in cancellation rates, cost-efficiency and adverse events.Methods and designIn this randomized, multi-centre, non-inferiority trial we aim to test the hypothesis that there is no significant difference in live birth rates between patients undergoing NC-FET versus AC-FET. The primary outcome will be live birth rate per embryo transfer procedure. Secondary outcomes will be ongoing and clinical pregnancy rate, cancellation rate, (serious) adverse events and cost-efficiency. Based on a live birth rate of 20% and a minimal clinical important difference of 7,5% (one-sided alpha 2,5%, beta 20%) a total of 1150 patients will be needed. Analyzes will be performed using both per protocol as well as intention to treat analyses.DiscussionThis prospective, randomized, non –inferiority trial aims to address the hypothesis that there is no significant difference in live birth rates between patients undergoing NC-FET versus patients undergoing AC-FET. Moreover it addresses cost-efficiency as well as the perceived burden of both treatments.Trial registerNetherlands trial register (NTR): 1586
Highlights
Frozen thawed embryo transfer (FET) is a cost- effective adjunct to In Vitro Fertilization (IVF) or IVF-Intra Cytoplasmatic Sperm Injection (ICSI) treatment
This prospective, randomized, non –inferiority trial aims to address the hypothesis that there is no significant difference in live birth rates between patients undergoing natural cycle FET (NC-FET) versus patients undergoing artificial cycle FET (AC-FET)
Hypothesis The hypothesis to be tested is that there is no significant difference in live birth rates between NC-FET and AC-FET, but that NC-FET is more cost effective
Summary
Frozen thawed embryo transfer (FET) is a cost- effective adjunct to IVF or IVF-ICSI treatment. To optimize implantation several methods for endometrium preparation have been proposed. In an artificial cycle FET (AC-FET) estrogens and progesterone are administered to prepare the endometrium for implantation. In some patients embryo transfer is postponed for medical reasons (e.g. ovarian hyperstimulation syndrome). Cryopreservation of these embryos provides both physicians and patients a safe, successful and presumably cost-efficient option [1,2,3]. Recent development and implementation of single embryo transfer strategies in IVF and IVF -ICSI programs has increased the importance of successful frozen thawed embryo transfer (FET) programs. Several methods for endometrium preparation have been developed
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