Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART): A study protocol for a randomised controlled trial

Sacha Stormlund*, Kristine Løssl, Anne Zedeler, Jeanette Bogstad, Lisbeth Prætorius, Henriette Svarre Nielsen, Mona Bungum, Sven O. Skouby, Anne Lis Mikkelsen, Anders Nyboe Andersen, Christina Bergh, Peter Humaidan, Anja Pinborg

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Introduction Pregnancy rates after frozen embryo transfer (FET) have improved in recent years and are now approaching or even exceeding those obtained after fresh embryo transfer. This is partly due to improved laboratory techniques, but may also be caused by a more physiological hormonal and endometrial environment in FET cycles. Furthermore, the risk of ovarian hyperstimulation syndrome is practically eliminated in segmentation cycles followed by FET and the use of natural cycles in FETs may be beneficial for the postimplantational conditions of fetal development. However, a freeze-all strategy is not yet implemented as standard care due to limitations of large randomised trials showing a benefit of such a strategy. Thus, there is a need to test the concept against standard care in a randomised controlled design. This study aims to compare ongoing pregnancy and live birth rates between a freeze-all strategy with gonadotropin-releasing hormone (GnRH) agonist triggering versus human chorionic gonadotropin (hCG) trigger and fresh embryo transfer in a multicentre randomised controlled trial. Methods and analysis Multicentre randomised, controlled, double-blinded trial of women undergoing assisted reproductive technology treatment including 424 normo-ovulatory women aged 18-39 years from Denmark and Sweden. Participants will be randomised (1:1) to either (1) GnRH agonist trigger and single vitrified-warmed blastocyst transfer in a subsequent hCG triggered natural menstrual cycle or (2) hCG trigger and single blastocyst transfer in the fresh (stimulated) cycle. The primary endpoint is to compare ongoing pregnancy rates per randomised patient in the two treatment groups after the first single blastocyst transfer. Ethics and dissemination The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committees in Denmark and Sweden. The results of the study will be publically disseminated. Trial registration number NCT02746562; Pre-results.

OriginalsprogEngelsk
Artikelnummere016106
TidsskriftBMJ Open
Vol/bind7
Udgave nummer7
Antal sider7
ISSN2044-6055
DOI
StatusUdgivet - 2017
Udgivet eksterntJa

Fingeraftryk

Chorionic Gonadotropin
Gonadotropin-Releasing Hormone
Randomized Controlled Trials
Denmark
Helsinki Declaration
Ovarian Hyperstimulation Syndrome
Ethics

Citer dette

Stormlund, Sacha ; Løssl, Kristine ; Zedeler, Anne ; Bogstad, Jeanette ; Prætorius, Lisbeth ; Nielsen, Henriette Svarre ; Bungum, Mona ; Skouby, Sven O. ; Mikkelsen, Anne Lis ; Andersen, Anders Nyboe ; Bergh, Christina ; Humaidan, Peter ; Pinborg, Anja. / Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART) : A study protocol for a randomised controlled trial. I: BMJ Open. 2017 ; Bind 7, Nr. 7.
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title = "Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART): A study protocol for a randomised controlled trial",
abstract = "Introduction Pregnancy rates after frozen embryo transfer (FET) have improved in recent years and are now approaching or even exceeding those obtained after fresh embryo transfer. This is partly due to improved laboratory techniques, but may also be caused by a more physiological hormonal and endometrial environment in FET cycles. Furthermore, the risk of ovarian hyperstimulation syndrome is practically eliminated in segmentation cycles followed by FET and the use of natural cycles in FETs may be beneficial for the postimplantational conditions of fetal development. However, a freeze-all strategy is not yet implemented as standard care due to limitations of large randomised trials showing a benefit of such a strategy. Thus, there is a need to test the concept against standard care in a randomised controlled design. This study aims to compare ongoing pregnancy and live birth rates between a freeze-all strategy with gonadotropin-releasing hormone (GnRH) agonist triggering versus human chorionic gonadotropin (hCG) trigger and fresh embryo transfer in a multicentre randomised controlled trial. Methods and analysis Multicentre randomised, controlled, double-blinded trial of women undergoing assisted reproductive technology treatment including 424 normo-ovulatory women aged 18-39 years from Denmark and Sweden. Participants will be randomised (1:1) to either (1) GnRH agonist trigger and single vitrified-warmed blastocyst transfer in a subsequent hCG triggered natural menstrual cycle or (2) hCG trigger and single blastocyst transfer in the fresh (stimulated) cycle. The primary endpoint is to compare ongoing pregnancy rates per randomised patient in the two treatment groups after the first single blastocyst transfer. Ethics and dissemination The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committees in Denmark and Sweden. The results of the study will be publically disseminated. Trial registration number NCT02746562; Pre-results.",
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author = "Sacha Stormlund and Kristine L{\o}ssl and Anne Zedeler and Jeanette Bogstad and Lisbeth Pr{\ae}torius and Nielsen, {Henriette Svarre} and Mona Bungum and Skouby, {Sven O.} and Mikkelsen, {Anne Lis} and Andersen, {Anders Nyboe} and Christina Bergh and Peter Humaidan and Anja Pinborg",
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doi = "10.1136/bmjopen-2017-016106",
language = "English",
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Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART) : A study protocol for a randomised controlled trial. / Stormlund, Sacha; Løssl, Kristine; Zedeler, Anne; Bogstad, Jeanette; Prætorius, Lisbeth; Nielsen, Henriette Svarre; Bungum, Mona; Skouby, Sven O.; Mikkelsen, Anne Lis; Andersen, Anders Nyboe; Bergh, Christina; Humaidan, Peter; Pinborg, Anja.

I: BMJ Open, Bind 7, Nr. 7, e016106, 2017.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Comparison of a 'freeze-all' strategy including GnRH agonist trigger versus a 'fresh transfer' strategy including hCG trigger in assisted reproductive technology (ART)

T2 - A study protocol for a randomised controlled trial

AU - Stormlund, Sacha

AU - Løssl, Kristine

AU - Zedeler, Anne

AU - Bogstad, Jeanette

AU - Prætorius, Lisbeth

AU - Nielsen, Henriette Svarre

AU - Bungum, Mona

AU - Skouby, Sven O.

AU - Mikkelsen, Anne Lis

AU - Andersen, Anders Nyboe

AU - Bergh, Christina

AU - Humaidan, Peter

AU - Pinborg, Anja

PY - 2017

Y1 - 2017

N2 - Introduction Pregnancy rates after frozen embryo transfer (FET) have improved in recent years and are now approaching or even exceeding those obtained after fresh embryo transfer. This is partly due to improved laboratory techniques, but may also be caused by a more physiological hormonal and endometrial environment in FET cycles. Furthermore, the risk of ovarian hyperstimulation syndrome is practically eliminated in segmentation cycles followed by FET and the use of natural cycles in FETs may be beneficial for the postimplantational conditions of fetal development. However, a freeze-all strategy is not yet implemented as standard care due to limitations of large randomised trials showing a benefit of such a strategy. Thus, there is a need to test the concept against standard care in a randomised controlled design. This study aims to compare ongoing pregnancy and live birth rates between a freeze-all strategy with gonadotropin-releasing hormone (GnRH) agonist triggering versus human chorionic gonadotropin (hCG) trigger and fresh embryo transfer in a multicentre randomised controlled trial. Methods and analysis Multicentre randomised, controlled, double-blinded trial of women undergoing assisted reproductive technology treatment including 424 normo-ovulatory women aged 18-39 years from Denmark and Sweden. Participants will be randomised (1:1) to either (1) GnRH agonist trigger and single vitrified-warmed blastocyst transfer in a subsequent hCG triggered natural menstrual cycle or (2) hCG trigger and single blastocyst transfer in the fresh (stimulated) cycle. The primary endpoint is to compare ongoing pregnancy rates per randomised patient in the two treatment groups after the first single blastocyst transfer. Ethics and dissemination The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committees in Denmark and Sweden. The results of the study will be publically disseminated. Trial registration number NCT02746562; Pre-results.

AB - Introduction Pregnancy rates after frozen embryo transfer (FET) have improved in recent years and are now approaching or even exceeding those obtained after fresh embryo transfer. This is partly due to improved laboratory techniques, but may also be caused by a more physiological hormonal and endometrial environment in FET cycles. Furthermore, the risk of ovarian hyperstimulation syndrome is practically eliminated in segmentation cycles followed by FET and the use of natural cycles in FETs may be beneficial for the postimplantational conditions of fetal development. However, a freeze-all strategy is not yet implemented as standard care due to limitations of large randomised trials showing a benefit of such a strategy. Thus, there is a need to test the concept against standard care in a randomised controlled design. This study aims to compare ongoing pregnancy and live birth rates between a freeze-all strategy with gonadotropin-releasing hormone (GnRH) agonist triggering versus human chorionic gonadotropin (hCG) trigger and fresh embryo transfer in a multicentre randomised controlled trial. Methods and analysis Multicentre randomised, controlled, double-blinded trial of women undergoing assisted reproductive technology treatment including 424 normo-ovulatory women aged 18-39 years from Denmark and Sweden. Participants will be randomised (1:1) to either (1) GnRH agonist trigger and single vitrified-warmed blastocyst transfer in a subsequent hCG triggered natural menstrual cycle or (2) hCG trigger and single blastocyst transfer in the fresh (stimulated) cycle. The primary endpoint is to compare ongoing pregnancy rates per randomised patient in the two treatment groups after the first single blastocyst transfer. Ethics and dissemination The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committees in Denmark and Sweden. The results of the study will be publically disseminated. Trial registration number NCT02746562; Pre-results.

KW - ART

KW - FET

KW - Freeze-all

KW - Ongoing pregnancy rate

KW - OPR

KW - RCT

U2 - 10.1136/bmjopen-2017-016106

DO - 10.1136/bmjopen-2017-016106

M3 - Journal article

C2 - 28760794

AN - SCOPUS:85026732339

VL - 7

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 7

M1 - e016106

ER -