Komiya et al recently sent a letter to the editor¹ raising issues of reliability and validity of our study “Stress Management and in Vitro Fertilization (IVF): A Pilot Randomized Controlled Trial”.² Their comments focused on the default of the registration, the absence of any mention of case dropout, the ambiguity in the details of IVF treatment and the lack of specific figures on the background of the participants.

However, the principles of CONSORT 2010 cannot be applied to Pilot Randomized and Feasibility Trials, only to Randomized Trials (RTs) or Randomized Controlled Trials (RCTs). Similarly, the CONSORT Extension 2016 suggested some principles for Pilot and Feasibility Trials, but again it does not directly apply to internal pilot studies, non-randomized pilot and feasibility studies, or phase II studies.^3,4 Many international journals do not require registration for Pilot and Feasibility Trials, but only for RTs or RCTs,⁵ granted that clinical trial registration is not an indicator of low risk of bias.⁶

Thanks to the useful comments by Komiya et al, our article² now includes online “Supplementary Materials” in which we clarify all their points one by one.  Specifically, the Material and Method section of Supplementary Materials includes details for the Registration, the Flow Chart and the IVF Treatment, and the Results section includes details for the Background of the Participants. Thus, we believe that the level of reliability and validity of the study can be now examined and ensured.

Maria Koumparou
Second Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Aretaieio Hospital, Athens, Greece

Panagiotis Bakas
Second Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Aretaieio Hospital, Athens, Greece

Konstantinos Pantos
IVF Unit at Genesis Athens Clinic, Athens, Greece

Marina Economou
First Department of Psychiatry, National and Kapodistrian University of Athens, Eginition Hospital, Athens, Greece

George Chrousos
University Research Institute of Maternal and Child Health and Precision Medicine, National and Kapodistrian University of Athens, Medical School

References

1. Komiya S, Banno M, Itagaki Y. Regarding "Stress management and In Vitro Fertilization (IVF): A pilot randomized controlled trial". Psychiatriki 2022, 10.22365/jpsych.2022.076
2. Koumparou M, Bakas P, Pantos K, Economou M, Chrousos G. Stress management and In Vitro Fertilization (IVF): A pilot randomized controlled trial. Psychiatriki 2021, 32:290-299, doi: 10.22365/jpsych.2021.029
3. Eldridge SM, Chan CL, Campbell MJ, Bond CV, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomized pilot and feasibility trials. BMJ 2016, 355: i5239, doi.org/10.1136/bmj.i5239.
4. Thabane L, Hopewell S, Lancaster GA, Bond CM, Coleman CL, Campbell MJ, Eldridge SM. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud 2016, 20:25, doi.org/10.1186/s40814-016-0065-z.
5. Trinquart L, Dunn AG, Bourgeois FT. Registration of published randomized trials: a systematic review and meta-analysis. BMC Med 2018, 16:173, doi.org/10.1186/s12916-018-1168-6
6. Farquhar CM, Showell MG, Showell EAE, Beetham P, Baak N, Mourad S, Jordan VMB. Clinical trial registration was not an indicator for low risk of bias. J Clin Epidemiol 2017, 84:47-53, doi.10.1016/j.jclinepi.2016.11.011

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