Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial
Introduction Despite the high number of frozen embryo transfer (FET) cycles being conducted (190 000 cycles/year) in Europe, the timing of blastocyst transfer and the use of luteal phase progesterone support in modified natural cycle FET (mNC-FET) in assisted reproductive technologies are controvers...
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BMJ Publishing Group
2019-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/12/e031811.full |
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| author | Marte Saupstad Nina La Cour Freiesleben Sven Olaf Skouby Lars Franch Andersen Ulla Breth Knudsen Kathrine Birch Petersen Merete Husth Anne Egeberg Morten Rønn Petersen Søren Ziebe Anders Nyboe Andersen Kristine Løssl Anja Pinborg |
| author_facet | Marte Saupstad Nina La Cour Freiesleben Sven Olaf Skouby Lars Franch Andersen Ulla Breth Knudsen Kathrine Birch Petersen Merete Husth Anne Egeberg Morten Rønn Petersen Søren Ziebe Anders Nyboe Andersen Kristine Løssl Anja Pinborg |
| author_sort | Marte Saupstad |
| collection | DOAJ |
| description | Introduction Despite the high number of frozen embryo transfer (FET) cycles being conducted (190 000 cycles/year) in Europe, the timing of blastocyst transfer and the use of luteal phase progesterone support in modified natural cycle FET (mNC-FET) in assisted reproductive technologies are controversial. In mNC-FET, the timing of blastocyst warming and transfer is determined according to the time of implantation in a natural cycle, aiming to reach blastocyst endometrial synchronicity. However, the optimal day of blastocyst transfer following ovulation trigger is not determined. In addition, the value of luteal phase support to maintain the endometrium remains uncertain. Thus, there is a need to identify the optimal timing of blastocyst warming and transfer and the effect of luteal phase support in a randomised controlled trial design. The aim of this randomised controlled trial is to investigate if progesterone supplementation from the early luteal phase until gestational age 8 weeks is superior to no progesterone supplementation and to assess if blastocyst warming and transfer 6 days after ovulation trigger is superior to 7 days after ovulation trigger in mNC-FET with live birth rates as the primary outcome.Methods and analysis Multicentre, randomised, controlled, single-blinded trial including 604 normo-ovulatory women aged 18–41 years undergoing mNC-FET with a high-quality blastocyst originating from their first to third in vitro fertilisation/intracytoplasmic sperm injection cycle. Participants are randomised (1:1:1:1) to either luteal phase progesterone or no luteal phase progesterone and to blastocyst warming and transfer on day 6 or 7 after human chorionic gonadotropin trigger. Only single blastocyst transfers will be performed.Ethics and dissemination The study is approved by the Danish Committee on Health Research Ethics (H-18025839), the Danish Medicines Agency (2018061319) and the Danish Data Protection Agency (VD-2018-381). The results of the study will be publicly disseminated.Trial registration number The study is registered in EudraCT (2018-002207-34) and on ClinicalTrials.gov (NCT03795220); Pre-results. |
| format | Article |
| id | doaj-art-754d5fe2a6fa4f72b4cab7fbc717beef |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-12-01 |
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| spelling | doaj-art-754d5fe2a6fa4f72b4cab7fbc717beef2024-12-02T20:55:13ZengBMJ Publishing GroupBMJ Open2044-60552019-12-0191210.1136/bmjopen-2019-031811Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trialMarte Saupstad0Nina La Cour Freiesleben1Sven Olaf Skouby2Lars Franch Andersen3Ulla Breth Knudsen4Kathrine Birch Petersen5Merete Husth6Anne Egeberg7Morten Rønn Petersen8Søren Ziebe9Anders Nyboe Andersen10Kristine Løssl11Anja Pinborg121 The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkDepartment of Obstetrics and Gynaecology, The Fertility Clinic, Hvidovre Hospital, Hvidovre, Denmark3 Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Herlev Hospital, Copenhagen, DenmarkDepartment of Obstetrics and Gynaecology, Fertility Clinic, Hillerød Hospital, Copenhagen University Hospital, Copenhagen, Denmark5 Kvindeafdelingen, Aarhus University Hospital, Horsens Hospital and the Institute of Clinical Medicine, Horsens, Denmark6 Department of Obstetrics and Gynaecology, The Fertility Clinic, Zealands University Hospital, Køge Hospital, Køge, Denmark7 Fertilitetsenheden og Center for Præimplantationsdiagnostik, Aalborg University Hospital, Aalborg, Denmark1 The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkThe Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Rigshospitalet, Copenhagen, DenmarkFertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark1 The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkFertility Department 4071, Rigshospitalet, Copenhagen University Hospital, Copenhagen, DenmarkFertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkIntroduction Despite the high number of frozen embryo transfer (FET) cycles being conducted (190 000 cycles/year) in Europe, the timing of blastocyst transfer and the use of luteal phase progesterone support in modified natural cycle FET (mNC-FET) in assisted reproductive technologies are controversial. In mNC-FET, the timing of blastocyst warming and transfer is determined according to the time of implantation in a natural cycle, aiming to reach blastocyst endometrial synchronicity. However, the optimal day of blastocyst transfer following ovulation trigger is not determined. In addition, the value of luteal phase support to maintain the endometrium remains uncertain. Thus, there is a need to identify the optimal timing of blastocyst warming and transfer and the effect of luteal phase support in a randomised controlled trial design. The aim of this randomised controlled trial is to investigate if progesterone supplementation from the early luteal phase until gestational age 8 weeks is superior to no progesterone supplementation and to assess if blastocyst warming and transfer 6 days after ovulation trigger is superior to 7 days after ovulation trigger in mNC-FET with live birth rates as the primary outcome.Methods and analysis Multicentre, randomised, controlled, single-blinded trial including 604 normo-ovulatory women aged 18–41 years undergoing mNC-FET with a high-quality blastocyst originating from their first to third in vitro fertilisation/intracytoplasmic sperm injection cycle. Participants are randomised (1:1:1:1) to either luteal phase progesterone or no luteal phase progesterone and to blastocyst warming and transfer on day 6 or 7 after human chorionic gonadotropin trigger. Only single blastocyst transfers will be performed.Ethics and dissemination The study is approved by the Danish Committee on Health Research Ethics (H-18025839), the Danish Medicines Agency (2018061319) and the Danish Data Protection Agency (VD-2018-381). The results of the study will be publicly disseminated.Trial registration number The study is registered in EudraCT (2018-002207-34) and on ClinicalTrials.gov (NCT03795220); Pre-results.https://bmjopen.bmj.com/content/9/12/e031811.full |
| spellingShingle | Marte Saupstad Nina La Cour Freiesleben Sven Olaf Skouby Lars Franch Andersen Ulla Breth Knudsen Kathrine Birch Petersen Merete Husth Anne Egeberg Morten Rønn Petersen Søren Ziebe Anders Nyboe Andersen Kristine Løssl Anja Pinborg Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial BMJ Open |
| title | Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial |
| title_full | Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial |
| title_fullStr | Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial |
| title_full_unstemmed | Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial |
| title_short | Preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen-thawed embryo transfers (mNC-FET): a study protocol for a randomised controlled multicentre trial |
| title_sort | preparation of the endometrium and timing of blastocyst transfer in modified natural cycle frozen thawed embryo transfers mnc fet a study protocol for a randomised controlled multicentre trial |
| url | https://bmjopen.bmj.com/content/9/12/e031811.full |
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