Is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? Study protocol of the multicentre, non-inferiority Antarctica-2 randomised controlled trial
Abstract STUDY QUESTION The objective of this trial is to compare the effectiveness and costs of true natural cycle (true NC-) frozen embryo transfer (FET) using urinary LH tests to modified NC-FET using repeated ultrasound monitoring and ovulation trigger to time FET in the NC. Secondary outcomes a...
Published in: | Human Reproduction Open |
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Language: | English |
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Oxford University Press (OUP)
2021
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Online Access: | http://dx.doi.org/10.1093/hropen/hoab035 http://academic.oup.com/hropen/advance-article-pdf/doi/10.1093/hropen/hoab035/40499224/hoab035.pdf https://academic.oup.com/hropen/article-pdf/2021/4/hoab035/44035820/hoab035.pdf |
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croxfordunivpr:10.1093/hropen/hoab035 2024-05-19T07:28:53+00:00 Is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? Study protocol of the multicentre, non-inferiority Antarctica-2 randomised controlled trial Zaat, T R de Bruin, J P Goddijn, M van Baal, M Benneheij, E B Brandes, E M Broekmans, F Cantineau, A E P Cohlen, B van Disseldorp, J Gielen, S C J P Groenewoud, E R van Heusden, A Kaaijk, E M Koks, C de Koning, C H Klijn, N F Lambalk, C B van der Linden, P J Q Manger, P van Oppenraaij, R H F Pieterse, Q Smeenk, J Visser, J van Wely, M Mol, F Netherlands Organisation for Health Research and Development 2021 http://dx.doi.org/10.1093/hropen/hoab035 http://academic.oup.com/hropen/advance-article-pdf/doi/10.1093/hropen/hoab035/40499224/hoab035.pdf https://academic.oup.com/hropen/article-pdf/2021/4/hoab035/44035820/hoab035.pdf en eng Oxford University Press (OUP) https://creativecommons.org/licenses/by-nc/4.0/ Human Reproduction Open volume 2021, issue 4 ISSN 2399-3529 journal-article 2021 croxfordunivpr https://doi.org/10.1093/hropen/hoab035 2024-04-25T07:59:51Z Abstract STUDY QUESTION The objective of this trial is to compare the effectiveness and costs of true natural cycle (true NC-) frozen embryo transfer (FET) using urinary LH tests to modified NC-FET using repeated ultrasound monitoring and ovulation trigger to time FET in the NC. Secondary outcomes are the cancellation rates of FET (ovulation before hCG or no dominant follicle, no ovulation by LH urine test, poor embryo survival), pregnancy outcomes (miscarriage rate, clinical pregnancy rates, multiple ongoing pregnancy rates, live birth rates, costs) and neonatal outcomes (including gestational age, birthweight and sex, congenital abnormalities or diseases of babies born). WHAT IS KNOWN ALREADY FET is at the heart of modern IVF. To allow implantation of the thawed embryo, the endometrium must be prepared either by exogenous oestrogen and progesterone supplementation (artificial cycle (AC)-FET) or by using the NC to produce endogenous oestradiol before and progesterone after ovulation to time the transfer of the thawed embryo (NC-FET). During an NC-FET, women visit the hospital repeatedly and receive an ovulation trigger to time FET (i.e. modified (m)NC-FET or hospital-based monitoring). From the woman’s point of view, a more natural approach using home-based monitoring of the ovulation with LH urine tests to allow a natural ovulation to time FET may be desired (true NC-FET or home-based monitoring). STUDY DESIGN, SIZE, DURATION This is a multicentre, non-inferiority prospective randomised controlled trial design. Consenting women will undergo one FET cycle using either true NC-FET or mNC-FET based on randomisation. PARTICIPANTS/MATERIALS, SETTING, METHODS Based on our sample size calculation, the study group will consist of 1464 women between 18 and 45 years old who are scheduled for FET. Women with anovulatory cycles, women who need ovulation induction and women with a contra indication for pregnancy will be excluded. The primary outcome is ongoing pregnancy. Secondary outcomes are cancellation rates of FET, ... Article in Journal/Newspaper Antarc* Antarctica Oxford University Press Human Reproduction Open 2021 4 |
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Open Polar |
collection |
Oxford University Press |
op_collection_id |
croxfordunivpr |
language |
English |
description |
Abstract STUDY QUESTION The objective of this trial is to compare the effectiveness and costs of true natural cycle (true NC-) frozen embryo transfer (FET) using urinary LH tests to modified NC-FET using repeated ultrasound monitoring and ovulation trigger to time FET in the NC. Secondary outcomes are the cancellation rates of FET (ovulation before hCG or no dominant follicle, no ovulation by LH urine test, poor embryo survival), pregnancy outcomes (miscarriage rate, clinical pregnancy rates, multiple ongoing pregnancy rates, live birth rates, costs) and neonatal outcomes (including gestational age, birthweight and sex, congenital abnormalities or diseases of babies born). WHAT IS KNOWN ALREADY FET is at the heart of modern IVF. To allow implantation of the thawed embryo, the endometrium must be prepared either by exogenous oestrogen and progesterone supplementation (artificial cycle (AC)-FET) or by using the NC to produce endogenous oestradiol before and progesterone after ovulation to time the transfer of the thawed embryo (NC-FET). During an NC-FET, women visit the hospital repeatedly and receive an ovulation trigger to time FET (i.e. modified (m)NC-FET or hospital-based monitoring). From the woman’s point of view, a more natural approach using home-based monitoring of the ovulation with LH urine tests to allow a natural ovulation to time FET may be desired (true NC-FET or home-based monitoring). STUDY DESIGN, SIZE, DURATION This is a multicentre, non-inferiority prospective randomised controlled trial design. Consenting women will undergo one FET cycle using either true NC-FET or mNC-FET based on randomisation. PARTICIPANTS/MATERIALS, SETTING, METHODS Based on our sample size calculation, the study group will consist of 1464 women between 18 and 45 years old who are scheduled for FET. Women with anovulatory cycles, women who need ovulation induction and women with a contra indication for pregnancy will be excluded. The primary outcome is ongoing pregnancy. Secondary outcomes are cancellation rates of FET, ... |
author2 |
Netherlands Organisation for Health Research and Development |
format |
Article in Journal/Newspaper |
author |
Zaat, T R de Bruin, J P Goddijn, M van Baal, M Benneheij, E B Brandes, E M Broekmans, F Cantineau, A E P Cohlen, B van Disseldorp, J Gielen, S C J P Groenewoud, E R van Heusden, A Kaaijk, E M Koks, C de Koning, C H Klijn, N F Lambalk, C B van der Linden, P J Q Manger, P van Oppenraaij, R H F Pieterse, Q Smeenk, J Visser, J van Wely, M Mol, F |
spellingShingle |
Zaat, T R de Bruin, J P Goddijn, M van Baal, M Benneheij, E B Brandes, E M Broekmans, F Cantineau, A E P Cohlen, B van Disseldorp, J Gielen, S C J P Groenewoud, E R van Heusden, A Kaaijk, E M Koks, C de Koning, C H Klijn, N F Lambalk, C B van der Linden, P J Q Manger, P van Oppenraaij, R H F Pieterse, Q Smeenk, J Visser, J van Wely, M Mol, F Is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? Study protocol of the multicentre, non-inferiority Antarctica-2 randomised controlled trial |
author_facet |
Zaat, T R de Bruin, J P Goddijn, M van Baal, M Benneheij, E B Brandes, E M Broekmans, F Cantineau, A E P Cohlen, B van Disseldorp, J Gielen, S C J P Groenewoud, E R van Heusden, A Kaaijk, E M Koks, C de Koning, C H Klijn, N F Lambalk, C B van der Linden, P J Q Manger, P van Oppenraaij, R H F Pieterse, Q Smeenk, J Visser, J van Wely, M Mol, F |
author_sort |
Zaat, T R |
title |
Is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? Study protocol of the multicentre, non-inferiority Antarctica-2 randomised controlled trial |
title_short |
Is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? Study protocol of the multicentre, non-inferiority Antarctica-2 randomised controlled trial |
title_full |
Is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? Study protocol of the multicentre, non-inferiority Antarctica-2 randomised controlled trial |
title_fullStr |
Is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? Study protocol of the multicentre, non-inferiority Antarctica-2 randomised controlled trial |
title_full_unstemmed |
Is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? Study protocol of the multicentre, non-inferiority Antarctica-2 randomised controlled trial |
title_sort |
is home-based monitoring of ovulation to time frozen embryo transfer a cost-effective alternative for hospital-based monitoring of ovulation? study protocol of the multicentre, non-inferiority antarctica-2 randomised controlled trial |
publisher |
Oxford University Press (OUP) |
publishDate |
2021 |
url |
http://dx.doi.org/10.1093/hropen/hoab035 http://academic.oup.com/hropen/advance-article-pdf/doi/10.1093/hropen/hoab035/40499224/hoab035.pdf https://academic.oup.com/hropen/article-pdf/2021/4/hoab035/44035820/hoab035.pdf |
genre |
Antarc* Antarctica |
genre_facet |
Antarc* Antarctica |
op_source |
Human Reproduction Open volume 2021, issue 4 ISSN 2399-3529 |
op_rights |
https://creativecommons.org/licenses/by-nc/4.0/ |
op_doi |
https://doi.org/10.1093/hropen/hoab035 |
container_title |
Human Reproduction Open |
container_volume |
2021 |
container_issue |
4 |
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1799476391602814976 |