Reviewer’s report
Title: 
An innovative surgical approach: Suture fixation of the levonorgestrel-
releasing intrauterine system in the treatment of adenomyosis
Version: 
0 
Date: 
05 Feb 2022
Reviewer: 
Sergio Haimovich
Reviewer's report:
Please include all comments for the authors in this box rather than uploading
your report as an attachment. Please only upload as attachments annotated
versions of manuscripts, graphs, supporting materials or other aspects of your
report which cannot be included in a text format.
Dear author, the idea of making an IUD fixation inside the uterine cavity in
order to reduce the expulsion rate is not new, the Gynefix was designed for that
purpose.
You based your idea for the fixation need on big uterus due to the high expulsion
rate, based on the reference 4 and 5 of your manuscript.
"Although the uterine size is not considered as one of the contraindications for
the use of intrauterine devices (IUDs including LNG-IUS), it is recommended
that all IUDs be inserted in uteri at a depth below 9cm[4]" 
In the same publication, "Review article: Contraindications to IUD and IUS use
by Anita L.Nelson" she writes " Uterine cavities have different shapes and
cervical lengths vary [30]. Zhang et al. [31] reported that expulsion rates are not
related to the length of the uterine cavity from the external os to the fundus, as
measured with uterine sounding."
30. 
Kamal I, Hefnawi F, Ghoneim M, Talaat M, Abdalla M. Dimensional and
architectural disproportion between the intrauterine device and the uterine cavity.
A cause of bleeding. Fertil Steril 1971;22:514 - 21.
31 Zhang J, Feldblum PJ, Chi IC, Farr MG. Risk factors for copper T IUD
expulsion: an epidemiologic analysis. Contraception 1992; 46:427 - 33.
And the you added: "As Park et al. reported, 37.5% patients with large
symptomatic adenomyosis experienced LNG-IUS expulsion which almost
occurred during the first 6 months[5]" but Park at the same study states "There
was no significant difference in the uterine volume between the expulsion [266.5
mL (201e687 mL)] and without expulsion [248.5 mL (201e384 mL)] groups (p
¼ 0.406)."
This raises the question of the real necessity of a surgical procedures under
general anesthesia with a 25Fr devices to perform a fixation by stitches on the
uterine wall. In Park´s study (Clinical experiences of the levonorgestrel-releasing
intrauterine system in patients with large symptomatic adenomyosis), he
reinserted the expulsed devices and in 1 patient he did it for a third time.
I am not sure about the need of an additional surgical procedures both in terms of
risks for the patient and economical costs, comparing with a simple office IUD
reinsertion of the device, even if 
after "mastering the surgical skills, we only
spent 10 to 15 minutes for each operation."
I am sorry but I do not see the advantages or the need for the presented
technique.
Publons Reviewer Recognition
. Springer Nature can send verification of this
review directly to Publons (a subsidiary of Clarivate Analytics). If you would
like to take advantage of this service, please click on the “Yes” option below.
Your name, email address, title of the reviewed manuscript, name of the journal,
and date of your review submission (the “Review Data”) will then be transmitted
to Publons after the final decision on the manuscript has been made. If you have
already registered at Publons, they will notify you of the receipt of this review
and update your profile 
as per your settings and their policy. If you are not
registered with Publons, you will receive an email from them asking you to
register in order for them to be able to recognize your review on your new
profile page. Publons may use the Review Data to generate derivative metadata
for the benefit of Publons and you as a reviewer, carefully considering the
sensitivity of such information. For example, Publons may verify your record as
a reviewer by updating your profile published on its webservice if you have
registered for such service or help editors to identify candidate reviewers. Please
find the details of processing in Publons’ privacy policy
https://publons.com/about/terms
Yes
Declaration of competing interests
Please complete a declaration of competing
interests, considering the following questions:
1
. 
Have you in the past five years received reimbursements, fees, funding, or
salary from an organisation that may in any way gain or lose financially
from the publication of this manuscript, either now or in the future?
2
. 
Do you hold any stocks or shares in an organisation that may in any way
gain or lose financially from the publication of this manuscript, either now
or in the future?
3
. 
Do you hold or are you currently applying for any patents relating to the
content of the manuscript?
4
. 
Have you received reimbursements, fees, funding, or salary from an
organization that holds or has applied for patents relating to the content of
the manuscript?
5
. 
Do you have any other financial competing interests?
6
. 
Do you have any non-financial competing interests in relation to this
paper?
If you can answer no to all of the above, write 'I declare that I have no competing
interests' below. If your reply is yes to any, please give details below.
I do not have any conflict of interests
Reviewer Publication Consent.
 I agree for my report to be made available
under an Open Access Creative Commons CC-BY License (
http://creativecommons.org/licenses/by/4.0
) if this manuscript is accepted for
publication. Any comments that I do not wish to be included in the published
report have been included as confidential comments to the editor, which will not
be published.
If you are not happy for us to publish this report, please contact the
editorial office before completing the review.
If you wish, you can include your
name in your published report. Please note you must decide whether to include
your name at the start of the process and confirm this decision whenever
prompted. If you change your decision later, we will not be able to publish your
name.
I agree to the terms of the CC-BY 4.0 license; please publish my name with my
report.
Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
No
Are the methods sufficiently described to allow the study to be repeated?
No
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes