For cis-women it is well known that the vaginal microbiome – the composition of the bacterial and fungal flora found in the vagina – can play a central role in vaginal health and gynecology. This is in stark contrast to the biomedical knowledge about the neo-vaginal microbiome of trans women. Despite the fact that different forms of vaginoplasty have been practised in France for more than 60 years, there have been only very few studies that investigated long-term outcomes of those surgeries in general and for the microbial diversity in particular. While it is assumed that trans women’s neo-vagina are host to a similarly rich microbiome as cis women’s vaginas, its characteristics have not yet been researched. To be able to procure adequate gynecological health care to trans women in the future, it seems essential to learn more about its composition and dynamics.

The objective of this study is to gain a better understanding of the microbial diversity and composition of the microbiomes that are found in neo-vaginas. To that end we aim to analyze the neo-vaginal microbiome of several trans women and will also investigate whether different surgical techniques and post-operative care have an impact on its constitution. It is important to be aware that this study is not a clinical or medical study and not organized or carried out by medical doctors but rather presents a case of basic research. Given the lack of existing knowledge we hope that this study will provide the basic knowledge needed for future discoveries. As such this study does not have any therapeutic goals.

This consent form for this study can be signed electronically through the Open Humans platform. By signing it there the study staff will not get access to any personal information from you and it will not be able to link your data and responses to your mailing address. Your participation in this study will officially be considered when you electronically sign this information form and give your consent.

These are the steps that participants are asked to undertake:

1. Electronically sign your consent through Open Humans

2. You will then automatically be forwarded to a survey that asks you some details about your vaginoplasty surgery and post-operative care.

3. Following the survey you can take your microbiome sample, following the instructions that were delivered to you alongside the sampling kit

4. You can mail the samples back to the study staff using the prepaid envelope provided in the sampling kit

5. We will send your samples to a sequencing company (Genewiz), which will perform DNA sequencing of the bacterial and fungal microorganisms present in your sample. At the end of the study the sequencing company will destroy all samples and data. Furthermore, the sequencing will only be done on the microorganisms of your microbiome and not on any of your own DNA.

Your data will exclusively be used to understand the diversity of microbial organisms present in your microbiome and potential links of microbiome diversity to surgical and post-operative practices. No sociological studies will be conducted with your data. An anonymous identification code assigned through Open Humans will be used to link your survey responses to your microbiome sample while not allowing any links to any personal information (your name, address).

At the end of the study you will have access to your own anonymized microbiome data but due to potential sampling or sequencing errors we can not guarantee that we will be able to sequence your microbiome.

To participate in this study you must fulfill the following criteria:

• You are at least 18 years old

• You are able to understand this consent form and able to provide the electronic signature for it

• You had a vaginoplasty and are willing and able to provide a sample of your neo-vaginal microbiome as needed for this study

You can only participate in this study if you meet all the inclusion requirements listed above.

You can not participate in this study if:

• You are undergoing or have been undergoing any systemic or local antibiotic/antifungal treatment within the last 3 months of sampling

• You had an invasive urogenital surgery less than one month before the sampling

If at least one of those exclusion criteria above applies to you, then you can not participate in this study.

Sampling

Our sample protocol follows the standard sampling protocol that is published and recommended for the self-collection of vaginal microbiome samples by the manufacturer of the sampling kit (DNAGenotek, Kit: OMR-130).

The microbiome sampling protocol used in this study has been tested by one of the study investigators and is painless, though you might experience some minor discomfort during the sample collection and could experience some slight irritation of your neovagina.

Data Privacy & Anonymity

Our study itself does not collect any personal information about your participation. When you registered your initial interest in this study you submitted your mailing address to receive your sampling kit. This information was exclusively used to mail the sampling kit and is not and will not be tied to your physical microbiome sample, your microbiome sequencing data or your survey responses if you decide to participate in this study.

If you decide to participate in this study, your data will be pseudonymized through the use of the Open Humans platform. When you sign this consent form, Open Humans will create an 8-digit participant identifier for you. This code is stored on the servers of Open Humans and the link to your email address you used to register with Open Humans will be inaccessible to the study staff and this participant code will be used to link your microbiome sample data to the survey data and to communicate with you pseudonymously when the results of this study are available.

When you return your microbiome samples via mail you will be asked to only label them with your 8-digit participant identifier, so that your mail remains pseudonymous as well. The prepaid envelopes will be already addressed to the return sender, so no further work is needed on your part.