Is home-based monitoring of ovulution 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
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 c...
Published in: | Human Reproduction Open |
---|---|
Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
2021
|
Subjects: | |
Online Access: | https://hdl.handle.net/11370/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 https://research.rug.nl/en/publications/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 https://doi.org/10.1093/hropen/hoab035 https://pure.rug.nl/ws/files/204500409/hoab035.pdf |
id |
ftunigroningenpu:oai:pure.rug.nl:publications/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 |
---|---|
record_format |
openpolar |
institution |
Open Polar |
collection |
University of Groningen research database |
op_collection_id |
ftunigroningenpu |
language |
English |
topic |
embryo transfer ART freezing ovulation LH randomised controlled trial chorionic gonadotrophin ovulation induction ultrasonography ovarian follicle CYCLE |
spellingShingle |
embryo transfer ART freezing ovulation LH randomised controlled trial chorionic gonadotrophin ovulation induction ultrasonography ovarian follicle CYCLE 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 ovulution 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 |
topic_facet |
embryo transfer ART freezing ovulation LH randomised controlled trial chorionic gonadotrophin ovulation induction ultrasonography ovarian follicle CYCLE |
description |
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, ... |
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. |
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 ovulution 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 ovulution 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 ovulution 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 ovulution 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 ovulution 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 ovulution 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 |
publishDate |
2021 |
url |
https://hdl.handle.net/11370/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 https://research.rug.nl/en/publications/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 https://doi.org/10.1093/hropen/hoab035 https://pure.rug.nl/ws/files/204500409/hoab035.pdf |
genre |
Antarc* Antarctica |
genre_facet |
Antarc* Antarctica |
op_source |
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 2021 , ' Is home-based monitoring of ovulution 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 ' , Human reproduction open , vol. 2021 , no. 4 , hoab035 . https://doi.org/10.1093/hropen/hoab035 |
op_relation |
https://research.rug.nl/en/publications/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 |
op_rights |
info:eu-repo/semantics/openAccess |
op_doi |
https://doi.org/10.1093/hropen/hoab035 |
container_title |
Human Reproduction Open |
container_volume |
2021 |
container_issue |
4 |
_version_ |
1802644338355732480 |
spelling |
ftunigroningenpu:oai:pure.rug.nl:publications/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 2024-06-23T07:46:10+00:00 Is home-based monitoring of ovulution 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. 2021 application/pdf https://hdl.handle.net/11370/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 https://research.rug.nl/en/publications/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 https://doi.org/10.1093/hropen/hoab035 https://pure.rug.nl/ws/files/204500409/hoab035.pdf eng eng https://research.rug.nl/en/publications/4aeb87d3-6b69-49e9-aa64-b7e2b5499017 info:eu-repo/semantics/openAccess 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 2021 , ' Is home-based monitoring of ovulution 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 ' , Human reproduction open , vol. 2021 , no. 4 , hoab035 . https://doi.org/10.1093/hropen/hoab035 embryo transfer ART freezing ovulation LH randomised controlled trial chorionic gonadotrophin ovulation induction ultrasonography ovarian follicle CYCLE article 2021 ftunigroningenpu https://doi.org/10.1093/hropen/hoab035 2024-06-10T17:19:47Z 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 University of Groningen research database Human Reproduction Open 2021 4 |