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Open Access Highly Accessed Study protocol

Cryo-thawed embryo transfer: natural versus artificial cycle. A non-inferiority trial.(ANTARCTICA trial)

Eva R Groenewoud1*, Nick S Macklon2, Ben J Cohlen3 and on behalf of the ANTARCTICA trial study group

Author affiliations

1 UMCG, Groningen, The Netherlands

2 Complete Fertility Centre, Department of Obstetrics and Gynaecology, Division of Human Development and Health, University of Southampton, Southampton, UK

3 Fertility Centre Isala Clinics, Zwolle, The Netherlands

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Citation and License

BMC Women's Health 2012, 12:27  doi:10.1186/1472-6874-12-27

Published: 5 September 2012

Abstract

Background

Frozen 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 design

In 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.

Discussion

This 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 register

Netherlands trial register (NTR): 1586