Abstract
IntroductionIn clinical practice, the ideal time at which to perform a Frozen–thawed Embryo Transfer (FET) after a failed In-vitro Fertilization-embryo Transfer (IVF-ET) is still unclear to most practicing physicians. In addition, physicians often delay the introduction of FET due to concerns on the possible residual effects of ovarian hyperstimulation, which may interfere with the regular menstrual cycle. Moreover, given that most of the published studies on the topic are retrospective with contradictory findings, it is crucial to provide evidence-based randomized control guides for clinical practice.Methods/analysisThe study is a randomized, non-inferiority, parallel-group, controlled trial that will enroll a total of 732 women undergoing their first FET after a failed fresh embryo transfer (ET) cycle. The participants will then be randomized into two groups based on a computer-generated randomized list. The two groups include: (i) an immediate group were FET will be carried out during the first menstrual cycle after a failed fresh ET cycle and (ii) a delayed group where FET will be carried out during the second menstrual cycle after a failed fresh ET cycle. Primary outcomes will be defined as viable pregnancies with fetal heartbeats, diagnosed through pelvic ultrasonography after twelve weeks of gestation.Ethics and disseminationThe study was approved by the Ethics Committee of the Assisted Reproductive Medicine at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine (SDTCM/E-2020.2.01). In addition, written informed consent will be obtained from all the participants before the study. The results of this trial will be disseminated in a peer-reviewed journal.DiscussionCurrently, there is no consensus with regard to the duration after which the effects of ovarian stimulation are observed after a failed fresh ET and the optimal time required to begin FET. Moreover, no randomized controlled trial exists that compares the ongoing pregnancy rates after immediate versus delayed FET following a failed fresh ET cycle. Therefore, it is important to conduct a well-designed randomized trial to determine whether it is necessary to delay FET for at least one menstrual cycle after the failure of fresh ET.Clinical Trial RegistrationChiCTR2000033313 (http://www.chictr.org.cn/enIndex.aspx).
Highlights
In clinical practice, the ideal time at which to perform a Frozen–thawed Embryo Transfer (FET) after a failed In-vitro Fertilization-embryo Transfer (IVF-embryo transfer (ET)) is still unclear to most practicing physicians
In a small retrospective cohort study (n = 129), VolodarskyPerel et al found that postponing FET by at least one menstrual cycle after a failed fresh ET was beneficial for pregnancy outcomes compared to immediate FET
This was observed if a preceding long GnRH-agonist protocol for COS was used and if an artificial preparation was indicated for FET [22]
Summary
The ideal time at which to perform a Frozen–thawed Embryo Transfer (FET) after a failed In-vitro Fertilization-embryo Transfer (IVF-ET) is still unclear to most practicing physicians. Physicians often delay the introduction of FET due to concerns on the possible residual effects of ovarian hyperstimulation, which may interfere with the regular menstrual cycle. Methods/analysis: The study is a randomized, non-inferiority, parallel-group, controlled trial that will enroll a total of 732 women undergoing their first FET after a failed fresh embryo transfer (ET) cycle. Written informed consent will be obtained from all the participants before the study. The results of this trial will be disseminated in a peer-reviewed journal
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