You are here

  • Home
  • Archive
  • Volume 9, Issue 12
  • 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

Article Text

Article menu

Download PDFPDF

XML
Reproductive medicine
Protocol
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
  1. Marte Saupstad1,
  2. Nina La Cour Freiesleben2,
  3. Sven Olaf Skouby3,
  4. Lars Franch Andersen4,
  5. Ulla Breth Knudsen5,
  6. Kathrine Birch Petersen6,
  7. Merete Husth7,
  8. Anne Egeberg1,
  9. Morten Rønn Petersen1,
  10. Søren Ziebe1,
  11. Anders Nyboe Andersen1,
  12. Kristine Løssl1,
  13. Anja Pinborg1
  1. 1 The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
  2. 2 Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Hvidovre Hospital, Copenhagen, Denmark
  3. 3 Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Herlev Hospital, Copenhagen, Denmark
  4. 4 Department of Obstetrics and Gynaecology, The Fertility Clinic, Copenhagen University Hospital, Nordsjællands Hospital, Hillerød, Denmark
  5. 5 Kvindeafdelingen, Aarhus University Hospital, Horsens Hospital and the Institute of Clinical Medicine, Horsens, Denmark
  6. 6 Department of Obstetrics and Gynaecology, The Fertility Clinic, Zealands University Hospital, Køge Hospital, Køge, Denmark
  7. 7 Fertilitetsenheden og Center for Præimplantationsdiagnostik, Aalborg University Hospital, Aalborg, Denmark
  1. Correspondence to Marte Saupstad; marte.saupstad{at}regionh.dk

Abstract

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.

  • assisted reproductive technologies
  • frozen embryo transfer
  • progesterone
  • endometrial preparation
  • subfertility

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-031811

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors ANA, AP and KL (primary research group) participated in the conception, design and writing of the study protocol. KL, MS, ANA, NLCF and AP contributed to the revision and editing of the study protocol. MS, AP, KL, ANA, MRP, NLCF, SOS, UBK, KBP, LFA and MH will be involved in the recruitment of patients and the acquisition of data. MS wrote the first draft of this manuscript. MRP and UBK were involved in developing the laboratory criteria for the study. MS, AP, AE, ANA, KL, MRP, SZ, NLCF, SOS, UBK, KBP, LFA and MH were all involved in critical revision of the manuscript. All authors approved the final version of the manuscript to be submitted.

    • Funding The study is fully supported by Rigshospitalet’s Research Foundation and an unrestricted grant from Gedeon Richter (Forward Grant).

    • Disclaimer Gedeon Richter have not been involved in design of the study protocol, nor will they be involved in the conduct of the study or the analysis and reporting of the results.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.