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 be...
Published in: | BMC Women's Health |
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Format: | Article in Journal/Newspaper |
Language: | English |
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2012
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Online Access: | https://hdl.handle.net/11370/b361cabf-47a6-434c-818a-c1452bda3d7d https://research.rug.nl/en/publications/b361cabf-47a6-434c-818a-c1452bda3d7d https://doi.org/10.1186/1472-6874-12-27 https://pure.rug.nl/ws/files/54731924/1472_6874_12_27.pdf |
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ftunigroningenpu:oai:pure.rug.nl:publications/b361cabf-47a6-434c-818a-c1452bda3d7d 2024-06-02T07:56:53+00:00 Cryo-thawed embryo transfer:natural versus artificial cycle. A non-inferiority trial. (ANTARCTICA trial) Groenewoud, Eva R. Macklon, Nick S. Cohlen, Ben J. 2012-09-05 application/pdf https://hdl.handle.net/11370/b361cabf-47a6-434c-818a-c1452bda3d7d https://research.rug.nl/en/publications/b361cabf-47a6-434c-818a-c1452bda3d7d https://doi.org/10.1186/1472-6874-12-27 https://pure.rug.nl/ws/files/54731924/1472_6874_12_27.pdf eng eng https://research.rug.nl/en/publications/b361cabf-47a6-434c-818a-c1452bda3d7d info:eu-repo/semantics/openAccess Groenewoud , E R , Macklon , N S , Cohlen , B J & ANTARCTICA Trial Study Grp 2012 , ' Cryo-thawed embryo transfer : natural versus artificial cycle. A non-inferiority trial. (ANTARCTICA trial) ' , BMC Womens Health , vol. 12 , 27 . https://doi.org/10.1186/1472-6874-12-27 ENDOMETRIAL PREPARATION CRYOPRESERVED EMBRYOS IMPLANTATION REPLACEMENT CONCEPTION IMPACT article 2012 ftunigroningenpu https://doi.org/10.1186/1472-6874-12-27 2024-05-07T18:59:21Z 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. Article in Journal/Newspaper Antarc* Antarctica University of Groningen research database BMC Women's Health 12 1 |
institution |
Open Polar |
collection |
University of Groningen research database |
op_collection_id |
ftunigroningenpu |
language |
English |
topic |
ENDOMETRIAL PREPARATION CRYOPRESERVED EMBRYOS IMPLANTATION REPLACEMENT CONCEPTION IMPACT |
spellingShingle |
ENDOMETRIAL PREPARATION CRYOPRESERVED EMBRYOS IMPLANTATION REPLACEMENT CONCEPTION IMPACT Groenewoud, Eva R. Macklon, Nick S. Cohlen, Ben J. Cryo-thawed embryo transfer:natural versus artificial cycle. A non-inferiority trial. (ANTARCTICA trial) |
topic_facet |
ENDOMETRIAL PREPARATION CRYOPRESERVED EMBRYOS IMPLANTATION REPLACEMENT CONCEPTION IMPACT |
description |
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. |
format |
Article in Journal/Newspaper |
author |
Groenewoud, Eva R. Macklon, Nick S. Cohlen, Ben J. |
author_facet |
Groenewoud, Eva R. Macklon, Nick S. Cohlen, Ben J. |
author_sort |
Groenewoud, Eva R. |
title |
Cryo-thawed embryo transfer:natural versus artificial cycle. A non-inferiority trial. (ANTARCTICA trial) |
title_short |
Cryo-thawed embryo transfer:natural versus artificial cycle. A non-inferiority trial. (ANTARCTICA trial) |
title_full |
Cryo-thawed embryo transfer:natural versus artificial cycle. A non-inferiority trial. (ANTARCTICA trial) |
title_fullStr |
Cryo-thawed embryo transfer:natural versus artificial cycle. A non-inferiority trial. (ANTARCTICA trial) |
title_full_unstemmed |
Cryo-thawed embryo transfer:natural versus artificial cycle. A non-inferiority trial. (ANTARCTICA trial) |
title_sort |
cryo-thawed embryo transfer:natural versus artificial cycle. a non-inferiority trial. (antarctica trial) |
publishDate |
2012 |
url |
https://hdl.handle.net/11370/b361cabf-47a6-434c-818a-c1452bda3d7d https://research.rug.nl/en/publications/b361cabf-47a6-434c-818a-c1452bda3d7d https://doi.org/10.1186/1472-6874-12-27 https://pure.rug.nl/ws/files/54731924/1472_6874_12_27.pdf |
genre |
Antarc* Antarctica |
genre_facet |
Antarc* Antarctica |
op_source |
Groenewoud , E R , Macklon , N S , Cohlen , B J & ANTARCTICA Trial Study Grp 2012 , ' Cryo-thawed embryo transfer : natural versus artificial cycle. A non-inferiority trial. (ANTARCTICA trial) ' , BMC Womens Health , vol. 12 , 27 . https://doi.org/10.1186/1472-6874-12-27 |
op_relation |
https://research.rug.nl/en/publications/b361cabf-47a6-434c-818a-c1452bda3d7d |
op_rights |
info:eu-repo/semantics/openAccess |
op_doi |
https://doi.org/10.1186/1472-6874-12-27 |
container_title |
BMC Women's Health |
container_volume |
12 |
container_issue |
1 |
_version_ |
1800736600060067840 |