Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 19, 2024
Open Peer Review Period: Sep 19, 2024 - Nov 14, 2024
Date Accepted: Feb 25, 2025
(closed for review but you can still tweet)
Feasibility of a Progesterone Modified Natural Protocol (P4mNFET) for Frozen Embryo Transfer: A Pilot Cohort Study
ABSTRACT
Background:
With the existence of various frozen embryo transfer (FET) methods currently utilised in the field of assisted reproductive technologies (ART), debate surrounding which of these is superior still remains. The aim of all FET protocols is to prime the endometrium and time embryo transfer during the window of implantation. Current methods include the natural cycle FET (NFET), artificial cycle FET (AFET), ovulation induction (OI) and the modified natural cycle FET (mNFET). Each of these harbours, distinct advantages and disadvantages, namely, surrounding the timing of transfer and flexibility conferred through this process. More recently, a newer approach has been utilised whereby the need to monitor or trigger ovulation is circumvented, with luteal phase support commenced once certain follicle diameter and endometrial thickness criteria are met, but prior to ovulation. However, the research into this protocol has certain important limitations that our study seeks to address.
Objective:
To assess the feasibility of a Progesterone Modified Natural Cycle protocol for Frozen Embryo Transfer (P4mNFET). The primary outcome will be the presence of a corpus luteum on ultrasound on the day of embryo transfer. The secondary outcomes will include the number of clinic visits required per patient undergoing the protocol, biochemical pregnancy rate, and clinical pregnancy rate.
Methods:
We will conduct a prospective cohort study, recruiting 20 women undertaking FET at the Public Fertility Care of The Royal Women’s Hospital in Melbourne, Australia. These women will be matched to a control group who have undergone FET within the preceding 12 months of the study start date.
Results:
This project received ethics approval on 17th July 2024, with proposed commencement in September 2024, a duration of completion of 9 months, with aim to complete follow-up and submit study publication in September 2025.
Conclusions:
At the conclusion of this preliminary study, the aim would be to progress to a non-inferiority randomised controlled trial to compare P4mNFET to the true NFET (tNFET). Clinical Trial: Registered with ANZCTR and ClinicalTrials.Gov. Awaiting registration numbers. https://www.anzctr.org.au/. https://clinicaltrials.gov/
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