Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial
Introduction Vaginal progesterone supplementation is frequently given to patients receiving frozen embryo transfer (FET) in the natural cycle aiming to increase the chance of pregnancy and live birth. To date, only a few studies have investigated if progesterone supplementation is beneficial in thes...
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Online Access: | http://dx.doi.org/10.1136/bmjopen-2022-062400 https://syndication.highwire.org/content/doi/10.1136/bmjopen-2022-062400 |
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crjcrbmj:10.1136/bmjopen-2022-062400 2024-09-15T18:14:20+00:00 Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial Stadelmann, Caroline Bergh, Christina Brännström, Mats Olsen, Kristbjörg Heiður Khatibi, Ali Kitlinski, Margareta Liffner, Susanne Lundborg, Eva Rodriguez-Wallberg, Kenny A Strandell, Annika Westlander, Göran Widlund, Gabriella Magnusson, Åsa ALF Ferring Pharmaceuticals 2022 http://dx.doi.org/10.1136/bmjopen-2022-062400 https://syndication.highwire.org/content/doi/10.1136/bmjopen-2022-062400 en eng BMJ http://creativecommons.org/licenses/by-nc/4.0/ BMJ Open volume 12, issue 7, page e062400 ISSN 2044-6055 2044-6055 journal-article 2022 crjcrbmj https://doi.org/10.1136/bmjopen-2022-062400 2024-08-15T04:12:50Z Introduction Vaginal progesterone supplementation is frequently given to patients receiving frozen embryo transfer (FET) in the natural cycle aiming to increase the chance of pregnancy and live birth. To date, only a few studies have investigated if progesterone supplementation is beneficial in these cycles and the level of evidence for progesterone supplementation is very low. Methods and analysis The ProFET trial is a multicentre, open-label, randomised controlled trial powered for this investigation, including 1800 women with regular menstrual cycles (24–35 days), aged 18–43 years planned for natural cycle-FET receiving a single blastocyst for transfer. Participants are randomised (1:1:1) to either luteal phase progesterone for 3 weeks, luteal phase progesterone for 7 weeks or no luteal phase progesterone. The participating study centres consist of 12 in vitro fertilisation-clinics in Sweden and 1 in Iceland. The primary outcome is to investigate if luteal phase support (LPS) by vaginal progesterone increases the chance of a live birth per randomised patient in a natural FET cycle compared with no LPS. Ethics and dissemination The trial was approved by the Swedish Ethical Review Authority (ID 2020-06774, 2021-02822 and 2022-01502-02) and the Swedish Medical Products Agency (ID nr 5.1-2020-102613). All participants are required to provide written informed consent. The outcome of this study will be disseminated to the public through broadcasts, newspapers and presentations at scientific congresses as well as publications in international scientific journals. Trial registration number NCT04725864 . Article in Journal/Newspaper Iceland The BMJ BMJ Open 12 7 e062400 |
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The BMJ |
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crjcrbmj |
language |
English |
description |
Introduction Vaginal progesterone supplementation is frequently given to patients receiving frozen embryo transfer (FET) in the natural cycle aiming to increase the chance of pregnancy and live birth. To date, only a few studies have investigated if progesterone supplementation is beneficial in these cycles and the level of evidence for progesterone supplementation is very low. Methods and analysis The ProFET trial is a multicentre, open-label, randomised controlled trial powered for this investigation, including 1800 women with regular menstrual cycles (24–35 days), aged 18–43 years planned for natural cycle-FET receiving a single blastocyst for transfer. Participants are randomised (1:1:1) to either luteal phase progesterone for 3 weeks, luteal phase progesterone for 7 weeks or no luteal phase progesterone. The participating study centres consist of 12 in vitro fertilisation-clinics in Sweden and 1 in Iceland. The primary outcome is to investigate if luteal phase support (LPS) by vaginal progesterone increases the chance of a live birth per randomised patient in a natural FET cycle compared with no LPS. Ethics and dissemination The trial was approved by the Swedish Ethical Review Authority (ID 2020-06774, 2021-02822 and 2022-01502-02) and the Swedish Medical Products Agency (ID nr 5.1-2020-102613). All participants are required to provide written informed consent. The outcome of this study will be disseminated to the public through broadcasts, newspapers and presentations at scientific congresses as well as publications in international scientific journals. Trial registration number NCT04725864 . |
author2 |
ALF Ferring Pharmaceuticals |
format |
Article in Journal/Newspaper |
author |
Stadelmann, Caroline Bergh, Christina Brännström, Mats Olsen, Kristbjörg Heiður Khatibi, Ali Kitlinski, Margareta Liffner, Susanne Lundborg, Eva Rodriguez-Wallberg, Kenny A Strandell, Annika Westlander, Göran Widlund, Gabriella Magnusson, Åsa |
spellingShingle |
Stadelmann, Caroline Bergh, Christina Brännström, Mats Olsen, Kristbjörg Heiður Khatibi, Ali Kitlinski, Margareta Liffner, Susanne Lundborg, Eva Rodriguez-Wallberg, Kenny A Strandell, Annika Westlander, Göran Widlund, Gabriella Magnusson, Åsa Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial |
author_facet |
Stadelmann, Caroline Bergh, Christina Brännström, Mats Olsen, Kristbjörg Heiður Khatibi, Ali Kitlinski, Margareta Liffner, Susanne Lundborg, Eva Rodriguez-Wallberg, Kenny A Strandell, Annika Westlander, Göran Widlund, Gabriella Magnusson, Åsa |
author_sort |
Stadelmann, Caroline |
title |
Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial |
title_short |
Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial |
title_full |
Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial |
title_fullStr |
Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial |
title_full_unstemmed |
Vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (ProFET): protocol for a multicentre, open-label, randomised controlled trial |
title_sort |
vaginal progesterone as luteal phase support in natural cycle frozen-thawed embryo transfer (profet): protocol for a multicentre, open-label, randomised controlled trial |
publisher |
BMJ |
publishDate |
2022 |
url |
http://dx.doi.org/10.1136/bmjopen-2022-062400 https://syndication.highwire.org/content/doi/10.1136/bmjopen-2022-062400 |
genre |
Iceland |
genre_facet |
Iceland |
op_source |
BMJ Open volume 12, issue 7, page e062400 ISSN 2044-6055 2044-6055 |
op_rights |
http://creativecommons.org/licenses/by-nc/4.0/ |
op_doi |
https://doi.org/10.1136/bmjopen-2022-062400 |
container_title |
BMJ Open |
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12 |
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7 |
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e062400 |
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1810452103215185920 |