Dear authors, I read your RCT with great interest and have the following concerns:
1- Accurate reporting of methodology and data of RCT is essential, owing to its importance to guide clinical recommendations and policies. Discrepancies in RCT reporting is a serious concern that reflect manipulation of data and warrant investigation (1). In this RCT (2), many discrepancies in reporting of methodology, flow of participants, outcomes among the manuscript, presented abstracts in international conferences and protocol (3). I address them as the following:
Randomization
In the manuscript (2): Randomization done by an independent statistician
In the protocol (3): Randomization done by the clinician (the protocol was published after study start, so it is not expected to have a deviation)
Duration of randomization
In the manuscript (2): Between June 2014 and February 2019
35th ESHRE 2019 (5): Between June 2014 and January 2019 (Already the study reached the sample size in this report)
Discrepancies on the No. of patient randomized
In the manuscript (2): 421women, of whom 211 women were randomly allocated to ICI and 210 to IUI.
36th ESHRE 2020 (4): 419 women, of whom 211 women were randomly allocated to ICI and 208 to IUI.
35th ESHRE 2019 (5): 417 women, of whom 209 women were randomly allocated to ICI and 208 to IUI
Discrepancies in No. of patients per protocol analysis (No. of per protocol analysis in ESHRE abstract is much higher which is unlogic for incomplete data)
In the manuscript (2): 126 women in the ICI group and 140 women in the IUI group
36th ESHRE 2020 (4): 193 women in the ICI group and 193 women in the IUI group
Discrepancies in drop-out rate
In the manuscript (2): 8 women allocated to ICI and 5 women allocated to IUI did not start treatment
35th ESHRE 2019 (5): 10 women (5%) allocated to ICI and 10 women (5%) allocated to IUI did not start treatment mostly due to personal reasons (different reasons from the manuscript)
Discrepancies in clinical outcomes: I excluded 35th ESHRE and 36the ESHRE abstracts because data were not final, except for ongoing pregnancy because it is unlogic to be higher.
Outcome
Manuscript (2): Live birth per protocol analysis ICI (48/126) = 38%, IUI (79/140) = 56%
ASRM (6): ICI (49 women) = 38 %, IUI (80 women) = 56 %
36th ESHRE 2020 (4): NA
Comment: One more woman in ASRM abstract in each arm
Manuscript (2): Ongoing pregnancy per protocol analysis ICI (50/126) = 40%, IUI (80/140) = 57%
ASRM (6): ICI (50 women) = 39%, IUI (80 women) = 56 %
36th ESHRE 2020 (4): ICI (51/193) = 26%, IUI (76/193) = 39%
Comment: No. of patient per protocol was not reported, but we observed one less percentage in each arm in ASRM abstract.
Although the authors declared in 36th ESHRE 2020 that data will be available on July 2020, we found higher no. of ongoing pregnancy in ICI arm which is unlogic (it should be the same or less after collecting all data).
2- Given that group of authors should be considered when assessing RCT, and if one of the authors has a retraction this could add a concern to the study and make it highly suspectable to be flawed (DOI: 10.1186/s41073-023-00130-8). One of the authors has a retraction due to unethical authorship practices and problematic data (Stay away from authorship misconduct – Fertility and Sterility). This makes this study, in addition to discrepancies addressed above, suspectable to be flowed.
I think these concerns are reasonable for the authors to share their data in a public domain for readers.
Many thanks
I declare no competing conflict of interest
References
(1) Khan KS, Fawzy M, Chien P, et al. International multistakeholder consensus statement on post-publication integrity issues in randomized clinical trials by Cairo Consensus Group. Int J Gynaecol Obstet. 2025;169(3):1093-1115. doi:10.1002/ijgo.16118
(2) Kop PAL, van Wely M, Nap A, et al. Intracervical insemination versus intrauterine insemination with cryopreserved donor sperm in the natural cycle: a randomized controlled trial. Hum Reprod. 2022;37(6):1175-1182. doi:10.1093/humrep/deac071
(3) Kop P, van Wely M, Nap A, et al. The AID study: protocol for a randomised controlled trial of intrauterine insemination in the natural cycle compared with intracervical insemination in the natural cycle. BMJ Open. 2019;9(7):e026065. Published 2019 Jul 23. doi:10.1136/bmjopen-2018-026065
(4) Kop F, Van Wely M, De Melker A, Mol BW, Bernardus R, De Brucker M, Janssens P, Nap A, Cohlen B, Pieters J, Repping S, Van Der Veen F, Mochtar M. A randomized clinical trial comparing intracervical insemination and intrauterine insemination for donor sperm treatment in the natural cycle. Human reproduction. Conference: 36th annual meeting of the european human reproduction and embryology. ESHRE. Virtual meeting, 2020, 35 Suppl 1, i185.
(5) Kop P, Van Wely M, Nap A, Mol BW, Bernardus RE, De Brucker M, Janssens PM, Cohlen BJ, Pieters JJ, Repping S, Van der Veen F, Mochtar MH. A randomized clinical trial comparing intracervical insemination and intrauterine insemination for donor sperm treatment in the natural cycle. Human reproduction. Conference: 35th annual meeting of the european society of human reproduction and embryology. ESHRE. Vienna, austria., 2019, 34 Suppl 1, i190.
(6) Kop, Petronella A.L. et al. INTRACERVICAL INSEMINATION AND INTRAUTERINE INSEMINATION FOR DONOR SPERM TREATMENT IN THE NATURAL CYCLE: A RANDOMIZED CONTROLLED TRIAL. Fertility and Sterility, Volume 114, Issue 3, e101 – e102