Cryo-thawed embryo transfer: natural versus artificial cycle. A non-inferiority trial.(ANTARCTICA trial)
Cryo-thawed embryo transfer: natural versus artificial cycle. A non-inferiority trial.(ANTARCTICA trial)
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: 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.
27
Groenewoud, Eva R.
60e13b8b-2fe3-469d-9a7b-2f28ddfe6fef
Macklon, Nick S.
7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e
Cohlen, Ben J.
73615326-366f-46d3-8e6b-805293b26178
5 September 2012
Groenewoud, Eva R.
60e13b8b-2fe3-469d-9a7b-2f28ddfe6fef
Macklon, Nick S.
7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e
Cohlen, Ben J.
73615326-366f-46d3-8e6b-805293b26178
Groenewoud, Eva R., Macklon, Nick S. and Cohlen, Ben J.
(2012)
Cryo-thawed embryo transfer: natural versus artificial cycle. A non-inferiority trial.(ANTARCTICA trial).
BMC Women’s Health, 12 (1), .
(doi:10.1186/1472-6874-12-27).
(PMID:22950651)
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: 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.
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Published date: 5 September 2012
Organisations:
Human Development & Health
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Local EPrints ID: 346454
URI: http://eprints.soton.ac.uk/id/eprint/346454
PURE UUID: 8b4d6ae9-c378-415c-9349-602725f7d2ce
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Date deposited: 15 Jan 2013 14:06
Last modified: 14 Mar 2024 12:37
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Author:
Eva R. Groenewoud
Author:
Nick S. Macklon
Author:
Ben J. Cohlen
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