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<p>Generously, he offered us the ZP2 <em>Escherichia coli</em> clones for our experiments and gave us the contact of Dr Gagandeep Gahlay, who has also been working on ZP2 protein.</p> | <p>Generously, he offered us the ZP2 <em>Escherichia coli</em> clones for our experiments and gave us the contact of Dr Gagandeep Gahlay, who has also been working on ZP2 protein.</p> | ||
<h3>Safety and Reversibility</h3> | <h3>Safety and Reversibility</h3> | ||
− | <p><strong>Feedback: </strong>Our project was designed to have a kill switch for reversibility, which was initially thought to prevent the unintentional release of genetically modified commensal. But, Dr Gupta raised the concern of dissemination of | + | <p><strong>Feedback: </strong>Our project was designed to have a kill switch for reversibility, which was initially thought to prevent the unintentional release of genetically modified commensal. But, Dr Gupta raised the concern of dissemination of genetically modified commensal into other parts of our body and the environment.</p> |
<p>Integration: So, we went through some literature. To avoid the accidental release of GMOs, we planned to design <strong>a kill switch for biosafety</strong>.</p> | <p>Integration: So, we went through some literature. To avoid the accidental release of GMOs, we planned to design <strong>a kill switch for biosafety</strong>.</p> | ||
</div> | </div> | ||
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<div class="col-12 pt-5" style="text-align: justify;"> | <div class="col-12 pt-5" style="text-align: justify;"> | ||
<p>Dr Pathak is an experienced doctoral researcher with a demonstrated history of working in academic research about mammalian embryo development. We met her to get insights on the feasibility of our idea.</p> | <p>Dr Pathak is an experienced doctoral researcher with a demonstrated history of working in academic research about mammalian embryo development. We met her to get insights on the feasibility of our idea.</p> | ||
− | <p>She appreciated the novelty of our idea and gave us important pieces of advice on several aspects of our project. We were delighted to listen to her elaborate on the | + | <p>She appreciated the novelty of our idea and gave us important pieces of advice on several aspects of our project. We were delighted to listen to her elaborate on the mechanism of Zona Pellucida hardening and the working of biomolecules secreted from the cortical granules, including Ovastacin.</p> |
<h3><strong>Protein Modelling</strong></h3> | <h3><strong>Protein Modelling</strong></h3> | ||
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<h3><strong>Inclusivity</strong></h3> | <h3><strong>Inclusivity</strong></h3> | ||
− | <p><strong>Feedback:</strong> She raised the concern whether OviCloak will cater to | + | <p><strong>Feedback:</strong> She raised the concern whether OviCloak will cater to the contraceptive needs ofindividuals with conditions like <strong>PCOS</strong>.</p> |
<p><strong>Integration:</strong> We looked into literature and decided to meet a gynaecologist to know more about the hormonal levels in conditions like PCOS.</p> | <p><strong>Integration:</strong> We looked into literature and decided to meet a gynaecologist to know more about the hormonal levels in conditions like PCOS.</p> | ||
<h3><strong>Kill switch</strong></h3> | <h3><strong>Kill switch</strong></h3> | ||
<p><strong>Feedback</strong>: She raised <strong>the concern of leaky expression</strong> in the proposed model of the kill switch. Also, she asked us to check whether the introduction of Xylose could cause any adverse effects in the fallopian tube.</p> | <p><strong>Feedback</strong>: She raised <strong>the concern of leaky expression</strong> in the proposed model of the kill switch. Also, she asked us to check whether the introduction of Xylose could cause any adverse effects in the fallopian tube.</p> | ||
− | <p><strong>Integration:</strong> We decided to use the toxin-antitoxin system for the kill switch as it seems to control leaky expression. No literature showed the presence of Xylose in the | + | <p><strong>Integration:</strong> We decided to use the toxin-antitoxin system for the kill switch as it seems to control leaky expression. No literature showed the presence of Xylose in the human fallopian tube, ensuring efficient induction of Kill switch by Xylose.</p></div> |
</div> | </div> | ||
</div> | </div> | ||
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</div> | </div> | ||
<div class="col-12 pt-5" style="text-align: justify;"> | <div class="col-12 pt-5" style="text-align: justify;"> | ||
− | <p>Dr Prameela Menon | + | <p>Dr Prameela Menon is a Professor of Obstetrics & Gynaecology at Amala Institute of Medical Sciences. She has experience of 9 years in this field, we visited her to understand the significance of our project in a real-world set-up and to know more about women with PCOS.</p> |
− | <p>She appreciated the novelty of our project and enlightened us by introducing Hysterosalpingogram(HSG), a | + | <p>She appreciated the novelty of our project and enlightened us by introducing to Hysterosalpingogram(HSG), a potential delivery mode for OviCloak</p> |
<h3><strong>Project Design</strong></h3> | <h3><strong>Project Design</strong></h3> | ||
<p><strong>Feedback</strong>: She raised <strong>the concern regarding the progesterone-induced Ovastacin production</strong>, as the fertilisation window of the ovum is short. Even if the progesterone sensing molecule is sensitive to a low concentration of progesterone, under any circumstances, if there’s a late expression of the hormone, it may lead to the fertilisation of the ovum. </p> | <p><strong>Feedback</strong>: She raised <strong>the concern regarding the progesterone-induced Ovastacin production</strong>, as the fertilisation window of the ovum is short. Even if the progesterone sensing molecule is sensitive to a low concentration of progesterone, under any circumstances, if there’s a late expression of the hormone, it may lead to the fertilisation of the ovum. </p> | ||
<p><strong>Integration: </strong>This gave us a reason to look into an alternative for a progesterone regulated system.</p> | <p><strong>Integration: </strong>This gave us a reason to look into an alternative for a progesterone regulated system.</p> | ||
<h3><strong>Implementation </strong></h3> | <h3><strong>Implementation </strong></h3> | ||
− | <p><strong>Feedback:</strong> She pointed out that many techniques are used to | + | <p><strong>Feedback:</strong> She pointed out that many techniques are used to view inside the fallopian tube such as Hysterosalpingogram and suggested that modifying those techniques may be easier than modifying an IUD and coming up with an entirely new design. </p> |
− | <p><strong>Integration: </strong>This led us to meet a fertility expert and know more about it, as Hysterosalpingogram is widely used in fertility clinics. Eventually, we met with Dr Sidra Khot, an IVF Expert. </p> | + | <p><strong>Integration: </strong>This led us to meet a fertility expert and know more about it, as Hysterosalpingogram is widely used in fertility clinics. Eventually, we met with<strong> Dr Sidra Khot, an IVF Expert. </strong></p> |
<h3><strong>Inclusivity</strong></h3> | <h3><strong>Inclusivity</strong></h3> | ||
<p><strong>Feedback:</strong> We asked whether OviCloak can cater to the contraceptive needs of uterus owners with conditions like <strong>PCOS</strong> etc. She said even though they have irregular ovulation, the progesterone raises more than normal during ovulation. Thus eventually, OviCloak should work.</p> | <p><strong>Feedback:</strong> We asked whether OviCloak can cater to the contraceptive needs of uterus owners with conditions like <strong>PCOS</strong> etc. She said even though they have irregular ovulation, the progesterone raises more than normal during ovulation. Thus eventually, OviCloak should work.</p> | ||
− | <p><strong>Integration </strong>But, the literature studies showed the rise in | + | <p><strong>Integration </strong>But, the literature studies showed the rise in Progestrone, is lower in PCOS conditions,for this SRTF1 needs to be sensitive. We set out looking for alternatives. See<a class="text-primary" href="https://2021.igem.org/Team:IISER-Tirupati_India/Inclusivity"> Inclusivity</a></p> </div> |
</div> | </div> | ||
</div> | </div> | ||
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<div class="modal-content"> | <div class="modal-content"> | ||
<div class="modal-header"> | <div class="modal-header"> | ||
− | <h5 class="modal-title" id="exampleModalLabel"> | + | <h5 class="modal-title" id="exampleModalLabel">Kathy Walkling</h5> |
<button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close"></button> | <button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close"></button> | ||
</div> | </div> | ||
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<p>She gave us valuable insights and showed us the path to communicate our project to the larger community in the right way.</p> | <p>She gave us valuable insights and showed us the path to communicate our project to the larger community in the right way.</p> | ||
<h3><strong>Communication</strong></h3> | <h3><strong>Communication</strong></h3> | ||
− | <p><strong>Feedback</strong>: Initially, we used | + | <p><strong>Feedback</strong>: Initially, we used contents which were more focused on the scientific details for our project. Ms Kathy suggested using simple but impactful communication methods for our project. She pointed at the significance of bringing awareness of reproductive health along through the communication of our project.</p> |
− | <p><strong>Integration: </strong>According to her suggestions, we thought of<strong> simple strategies for communicating our project to the public</strong>. Besides our goal of educating people about synthetic biology, we decided to disseminate knowledge about sexual and reproductive health through webinars, Instagram lives sessions and many more creative methods. | + | <p><strong>Integration: </strong>According to her suggestions, we thought of<strong> simple strategies for communicating our project to the public</strong>. Besides our goal of educating people about synthetic biology,<strong> we decided to disseminate knowledge about sexual and reproductive health</strong> through webinars, Instagram lives sessions and many more creative methods.See <a class="text-primary" href="https://2021.igem.org/Team:IISER-Tirupati_India/Education">Education</a>.</p> |
<h3><strong>Human Practices</strong></h3> | <h3><strong>Human Practices</strong></h3> | ||
− | <p><strong>Feedback</strong>: Since we are working around a disparaging topic and people are not aware of the importance of eco-friendly contraceptives, she urged us to go | + | <p><strong>Feedback</strong>: Since we are working around a disparaging topic and people are not aware of the importance of eco-friendly contraceptives, she urged us to go through social science researches to come up with impactful data that would help us make the change. She encouraged us to conduct 'In-Depth Interviews' (IDI) with sexually active women to find out how to bridge the gap between the consumer and a novel green product. She suggested <strong>including more men in the awareness programs</strong>, as they play a crucial role in the choice of women's contraception. </p> |
− | <p><strong>Integration: </strong>We decided to conduct IDIs with people to get to know the real stories around contraceptives. But due to the | + | <p><strong>Integration: </strong>We decided to conduct IDIs with people to get to know the real stories around contraceptives. But due to the COVID-19 restrictions and the thought that the real talks around sexual and reproductive health should start from our homes, we started the conversation with our friends and family members.</p> </div> |
</div> | </div> | ||
</div> | </div> | ||
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<div class="col-12 pt-5" style="text-align: justify;"> | <div class="col-12 pt-5" style="text-align: justify;"> | ||
Dr Mehrunisa is a Retired Civil Surgeon in Kerala Health Service. | Dr Mehrunisa is a Retired Civil Surgeon in Kerala Health Service. | ||
− | She appreciated the idea and was optimistic about the idea being implemented in public sectors. She discussed the legal rights of women while undergoing contraceptive procedures | + | She appreciated the idea and was <strong>optimistic about the idea being implemented in public sectors</strong>. She discussed the legal rights of women while undergoing contraceptive procedures.<p> </div> |
− | + | ||
</div> | </div> | ||
</div> | </div> | ||
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<div class="modal-content"> | <div class="modal-content"> | ||
<div class="modal-header"> | <div class="modal-header"> | ||
− | <h5 class="modal-title" id="exampleModalLabel">Nalini Jameela</h5> | + | <h5 class="modal-title" id="exampleModalLabel">Ms Nalini Jameela</h5> |
<button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close"></button> | <button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close"></button> | ||
</div> | </div> | ||
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<h3><strong>Communication</strong></h3> | <h3><strong>Communication</strong></h3> | ||
− | <p><strong>Feedback</strong>: She also emphasised the importance of sex education from a | + | <p><strong>Feedback</strong>: She also emphasised the importance of sex education from a younger age to build more sexually empowered and responsible adults. Hence, we thought of making a<strong> curriculum for Comprehensive Sexuality Education (CSE) in colleges. </strong></p> |
<p><strong>Integration: </strong>We decided to meet experts to know the challenges and procedures to actualise that.</p> </div> | <p><strong>Integration: </strong>We decided to meet experts to know the challenges and procedures to actualise that.</p> </div> | ||
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</div> | </div> | ||
<div class="col-12 pt-5" style="text-align: justify;"> | <div class="col-12 pt-5" style="text-align: justify;"> | ||
− | <p>Dr.Vasudharani was the former member of the | + | <p>Dr.Vasudharani was the former member of the Women cell in our Institute; we met with her to get insights on the barriers in implementing CSE in the current curricula.</p> |
<p>She appreciated our idea and congratulated us on coming this far with our idea, despite all the barriers of the pandemic. We came to understand that preparing a curriculum and implementing it would be a long journey. </p> | <p>She appreciated our idea and congratulated us on coming this far with our idea, despite all the barriers of the pandemic. We came to understand that preparing a curriculum and implementing it would be a long journey. </p> | ||
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<div class="modal-content"> | <div class="modal-content"> | ||
<div class="modal-header"> | <div class="modal-header"> | ||
− | <h5 class="modal-title" id="exampleModalLabel"> | + | <h5 class="modal-title" id="exampleModalLabel">Prof Debjani Paul</h5> |
<button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close"></button> | <button type="button" class="btn-close" data-bs-dismiss="modal" aria-label="Close"></button> | ||
</div> | </div> | ||
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</div> | </div> | ||
<div class="col-12 pt-5" style="text-align: justify;"> | <div class="col-12 pt-5" style="text-align: justify;"> | ||
− | <p> | + | <p>Prof Paul is an Associate professor in the Department of Biosciences and Bioengineering at IIT Bombay. We met with her to discuss the mode of delivery of OviCloak. She appreciated how we have considered so many alternatives for our delivery mechanism.</p> |
<h3><strong>Implementation</strong></h3> | <h3><strong>Implementation</strong></h3> | ||
− | <p><strong>Feedback</strong>: We discussed with her the fluid behavior under the influence of ciliary-peristalsis and furthermore various ways we | + | <p><strong>Feedback</strong>: We discussed with her the fluid behavior under the influence of ciliary-peristalsis and furthermore various ways which we considered for injecting genetically modified bacteria, including direct delivery, two fluid delivery and injecting into the Ostia. Prof Paul helped us realise the challenges of each and suggested that <strong>using an existing method with minimum changes is the best solution. </strong></p> |
− | <p><strong>Integration: </strong>We decided to find more techniques like hysterosalpingogram (advised by Dr Prameela) | + | <p><strong>Integration: </strong>We decided to find more techniques like hysterosalpingogram (advised by Dr Prameela).</p> |
</div> | </div> | ||
</div> | </div> | ||
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<p>In the initial months of our project, we thought of<strong> improvising an IUD</strong> to deliver the genetically engineered bacteria into the fallopian tube. On reflection, we didn’t want to develop a device that would stay inside the uterus of the user.</p> | <p>In the initial months of our project, we thought of<strong> improvising an IUD</strong> to deliver the genetically engineered bacteria into the fallopian tube. On reflection, we didn’t want to develop a device that would stay inside the uterus of the user.</p> | ||
− | <p>We continued our quest for an alternative, and it was meeting with <strong> | + | <p>We continued our quest for an alternative, and it was meeting with <strong>Prof Debjani Paul, an Associate professor in the Department of Biosciences and Bioengineering at IIT Bombay</strong> that we realised the challenges of considered alternatives like direct delivery, two fluid delivery and injecting into the Ostia. Dr Prameela and Dr Paul suggested that <strong>using an existing method with minimum changes is the best solution</strong>. </p> |
<p>In the meeting with <strong>Dr Sidra Khot, an IVF expert</strong> we learned about hysterosalpingogram, Hysteroscopy and catheters. We knocked out hysterosalpingogram as it is only familiar to fertility experts leading to reduced accessibility. Similarly, Catheter needs a well-trained gynecologist for its operation.</p> | <p>In the meeting with <strong>Dr Sidra Khot, an IVF expert</strong> we learned about hysterosalpingogram, Hysteroscopy and catheters. We knocked out hysterosalpingogram as it is only familiar to fertility experts leading to reduced accessibility. Similarly, Catheter needs a well-trained gynecologist for its operation.</p> | ||
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<div class="info"> | <div class="info"> | ||
<h5>Dr Vasudharani Devanathan</h5> | <h5>Dr Vasudharani Devanathan</h5> | ||
− | <p>Council Of Students Activities Chair and former member of | + | <p>Council Of Students Activities Chair and former member of Women cell, IISER Tirupati</p> |
</div> | </div> | ||
</div> | </div> | ||
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<img class="hp-timeline-image" src="https://static.igem.org/mediawiki/2021/6/6b/T--IISER-Tirupati_India--Debjani.jpg" alt="..."> | <img class="hp-timeline-image" src="https://static.igem.org/mediawiki/2021/6/6b/T--IISER-Tirupati_India--Debjani.jpg" alt="..."> | ||
<div class="info"> | <div class="info"> | ||
− | <h5> | + | <h5>Prof Debjani Paul</h5> |
<p>Associate Professor, Department of Biosciences and Bioengineering, IIT Bombay</p> | <p>Associate Professor, Department of Biosciences and Bioengineering, IIT Bombay</p> | ||
</div> | </div> |
Revision as of 19:46, 20 October 2021
OviCloak, throughout its journey, endeavoured to be a people’s project. From brainstorming to implementation, we involved our stakeholders. Our vision was to make our stakeholders understand the design of the project, know their desire and close the loop between both.
OviCloak being a proposed synthetic biology alternative for existing contraceptives, demands thoughtfulness about whether it is responsible and good for the world. Through our human practices, we tried to achieve this via :
Our team initiated thoughtfulness from the brainstorming sessions in which the problems we wished to address spanned from poverty to plastic pollution. We came up with solutions using synthetic biology to tackle these problems. However, we also verified if our proposed synthetic biology methods are better than the existing solutions/proposed solutions to these problems.
“About 22.2 million unintended pregnancies in 43 developing countries are due to contraceptive failure.”
“Between 2000 and 2009, the use of modern contraceptives is seen to increase by only 2.1%. WHO points out that limited access to services, fear or experience of side-effects; poor quality of available services are the major reasons for this slower increase. “
“In India, an irreversible procedure like female sterilization is preferable for more than 75% of cases that take away the individual’s right to plan families.”
This caught our attention! We recognised that being an integral part of society, the lack of a sustainable & empowering contraceptive affects the safety of individuals globally & thus this issue demands the centre stage. We wished to bestow an effective and safe alternative to the 933 million contraceptive users through synthetic biology.
Thus, our journey towards OviCloak started.
Stakeholder analysis
The analysis section of The iGEMers Guide to the Future helped us contemplate the values that we want to embed for the potential users of OviCloak through the stakeholder/value matrix. Health (Safety), Environmental Safety, Autonomy/individual choice are values we wish to embed and as well as fulfilled by OviCloak.
Market Survey
Further, to understand what needs and values are our stakeholders looking forth in our project and to evaluate whether the values fulfilled OviCloak meet their preferences, we decided to conduct a market survey. We found that a significant fraction of the contraceptive users were seen to experience side effects, hence our vision of prioritising health safety will be endorsed by our stakeholders. Least to no side effects, environmental safety, reversibility and long-term action of the contraceptive were some of the attributes respondents felt important for their contraceptive.These are values OviCloak wishes to fulfil.
Thus, we felt that OviCloak would benefit the contraceptive users.
Market Survey PDF
Meeting with stakeholders
Through meetings with Stakeholders, We could understand the importance of some values which were left unaddressed.
-
SWOT Analysis
We performed a SWOT analysis to reflect the strength, weaknesses, opportunities and threats of our project.
-
Stakeholder identification
Identifying the stakeholders was the first step in comprehending the importance of the team and project being safe and responsible.
-
SWOT Analysis
From SWOT analysis, we understood the threats posed by our projects such as lack of awareness about contraception in civilians, horizontal gene transfer or biosafety and lack of funding.
-
The values and risks workshop
We attended the values and risks workshop conducted by iGEM Ambassadors.
-
Responsible Research
Our team strived to be responsible and safe throughout the project inside and outside labs by adhering to lab rules and COVID-19 protocols. Read more in Safety.
We understood that our project has a great potential to impact the world outside the lab. For this, we strived to set up a two-way dialogue between us and the world.
Our aim was to :
- Learn about the world outside the lab
- Integrate the learning into our project.
This was achieved by a strategic move by our team as the following :
Stakeholder Identification
Stakeholder identification which was done as a part of our reflection was the cornerstone for responsiveness.
Reaching out
Finding out the identified stakeholders and experts were challenging. The ongoing pandemic necessitated doing our human practices responsibly with limited personal contact.
With constant online search, we could find contacts (Mail Id, contact number) of experts. Social Platforms such as LinkedIn and Instagram helped us a lot in this step. Some experts were kind enough to introduce us to some other experts and stakeholders.
Engaging with stakeholders was still a challenge due to COVID-19 restrictions, so we thought why not start from our home. We conducted in-depth interviews with our family members of 18+ age, thereby initiating the conversation around sexual and reproductive health from our homes.
Engaging with stakeholders and Experts.
We opted for In-Depth Interviews for one-on-one engagement with our stakeholders and experts. While surveys came to the rescue to engage with a large population of stakeholders.
We strived to adhere to all COVID-19 regulations as well as ethics while doing human research. Read more in Safety.
Closing the loop
Analysis
We analysed the IDIs and Surveys. Surveys were analysed and infographics were made for better representation.
Integrating
Closing the loop between what is designed and desired is at the heart of our human practices. We strived to do that through :
- Discussing the feedback and selecting the relevant ones on the basis of values chosen.
- Conducting literature surveys or testing through mathematical modelling.
- Engaging with the stakeholder to get feedback on integration.
This is iterated throughout our project. This feedback and integration helped us build a people’s project.
Integrated Human Practices
How iHP moulded OviCloak
Our stakeholders played an unequivocal role in the shaping of OviCloak. Here, we highlight how our Human Practices informed our ethical, technical, safety and communication decisions and closed the loop between what is desired and designed.
To know details, see timeline below
Feasibility and Desirability
In our Initial social science research, we understood the need for a novel contraceptive.
- In addition to this, we conducted In-Depth Interviews to learn about the general opinion of people on existing contraceptives and their perspective on the need for new contraceptives. We also wanted to know about people’s views on OviCloak and the usage of a GMO for contraception. Keeping in view the COVID-19 restrictions, we conducted In-Depth Interviews with our family members and friends of 18+ age. Since our team members are from different parts of India, we could ensure the diversity of the respondents by conducting this with people at various locations in India.
See the detailed analysis of IDI here.
- Through reflection, we wished to embed safety and autonomy into our project. Interaction with stakeholders helped us understand the other values we left out and prioritise the values.
Read more in Reflection to know the needs or values we prioritized in our project’s design and the compromises made by us.
Broadening the spectrum of End-users
Iterative feedback from our stakeholders and their integration helped us make the project good for the world, especially for the communities left uncared for.
Dr Madhulika Pathak , a doctoral researcher with a demonstrated history of working in academic research about mammalian embryo development helped us realize that our approach to contraception has been limited to the ideal reproductive tract anatomy and hormonal levels of "women". We were asked whether our contraceptive caters to the needs of individuals with Poly Cystic Ovarian Syndrome. We set out to improve upon this fact by connecting with another expert, Dr Prameela Menon- A gynecologist. She gave us direction in the improvement needed in the design.
Frequent discussions with our Institute's LGBTQIA+ awareness club, "Rainbows of IISER Tirupati", helped us understand the importance of individuals belonging to the transmasculine and intersex individuals as our stakeholders. This inspired us to call OviCloak a "novel female contraceptive" instead of a "novel contraceptive for women as "woman" only refers to a particular gender of the gender binary.
In the meeting with the NGO "Sex Education for India", we understood the need for a more inclusive term as the term "female" is not inclusive of individuals belonging to the "transmasculine" and "intersex" communities who don't identify with the words "male" and "female". After brainstorming, we came up with a more inclusive title, 'A novel contraceptive for Uterus owners'
In our initial quest to broaden our end-user spectrum, we came across conditions like Congenital adrenal hyperplasia (CAH), Turner Syndrome, and people from a transmasculine spectrum who could be our potential stakeholders. In the meeting with Dr Frances Grimstad, she pointed out a condition called Cloacal Exstrophy, which can be considered.
Thus, OviCloak became a contraceptive for all uterus owners.
Design of Genetic Circuit
Initially, we had a progesterone-induced approach for regulating Ovastacin production. In the meeting with Dr Satish Gupta, an Emeritus Scientist at the National Institute of Immunology, he pointed out the importance of sensitivity of the transcription factor, SRTF1, for efficient regulation during minimal Progesterone production. Hence, we set out to look for alternative sensing molecules as we found SRTF1 has less sensitivity to sense the minimal concentration of Progesterone during the onset of ovulation[2].
Meanwhile, we met with Dr Prameela Menon, a gynaecologist. She raised the concern regarding the late expression of Ovastacin, as the fertilisation window is very short. So, we set out to look into an alternative design for the regulation of Ovastacin.
Eventually, we came up with Progesterone repressed regulatory systems for Ovastacin production, which overcame the previous concerns.
Safety
The prime value we wished to embed in OviCloak was Safety, which is not complete without Biosafety. Hence, we gave importance to the kill switch module of our project and most importantly, we made a constant effort to get feedback and integrate them into our kill switches.
Initially, our project was designed to have a kill switch for reversibility which was thought to prevent the unintentional release of genetically modified commensal. But, Dr Gupta raised the concern of dissemination of genetically modified commensal into the environment. So, we reflected on the scenarios where engineered bacteria can escape the fallopian tube. This led to thorough literature surveys [3][4] and designing a kill switch for biosafety.
In the meeting with Dr Pathak , she raised the concern of leaky expression in the proposed model of the kill switches. We set out to look for a better design with non-leaky expressions. Eventually, we decided to use the toxin-antitoxin system for the kill switch as it seems to control leaky expression [5].
Once the genetic circuit design for both the kill switches was ready, we met with Dr Brenda Wilson, a microbiologist from the University of Illinois. Dr Wilson pointed out the possibility of a toxic shock from the endotoxins released on the activation of the kill switch. She suggested alternatives to the kill switch, such as using antibiotics and a replication inhibitor called Psoralen, which can prevent the growth of bacteria instead of killing them. This was indeed a matter of thought which we wish to incorporate into our kill switch in the future.
Bringing OviCloak into Real world
Our meetings with experts helped us understand the challenges and scope of improvement to bring OviCloak to the real world.
Delivery System
In the initial months of our project, we thought of improvising an IUD to deliver the genetically engineered bacteria into the fallopian tube. On reflection, we didn’t want to develop a device that would stay inside the uterus of the user.
We continued our quest for an alternative, and it was meeting with Prof Debjani Paul, an Associate professor in the Department of Biosciences and Bioengineering at IIT Bombay that we realised the challenges of considered alternatives like direct delivery, two fluid delivery and injecting into the Ostia. Dr Prameela and Dr Paul suggested that using an existing method with minimum changes is the best solution.
In the meeting with Dr Sidra Khot, an IVF expert we learned about hysterosalpingogram, Hysteroscopy and catheters. We knocked out hysterosalpingogram as it is only familiar to fertility experts leading to reduced accessibility. Similarly, Catheter needs a well-trained gynecologist for its operation.
Thus, by integrating the feedback from the stakeholders mentioned above, we decided to deliver the genetically modified bacteria with a technique called Hysteroscopy, as it is more accessible.
Dr Brenda and Ms Nalini raised concerns regarding the user-friendliness of our delivery system. Finding a delivery system, which can deliver the genetically engineered bacteria in a more user-friendly way is our future prospective.
Implementation
Dr Praveen Vemula, a translational researcher, made us understand the importance of proof of concept for each aspect of our project. We were advised to go through safety regulatory guidelines and plan the proof of concept accordingly for biosafety.
Dr Diana Blithe, The Chief of Contraceptive Development Program at the National Institutes of Health, U.S. Department of Health and Human Services and the Co-director of the Contraceptive Clinical Trials Network helped us understand the steps in pre-clinical and clinical trials which OviCloak have to undergo before potential approval by Regulatory boards.
To figure out the possibilities of a business model, we met Dr Deepika Upadhyay, an associate professor at the Department of Management Studies at Maharshi Dayanand Saraswati University and brainstormed the end-users. This led us to conclude that our product could be better marketed to an urban/suburban population and subsequently cost subsidised to cater to rural populations’ needs.
We met with Six experts from FHI 360, a nonprofit human development organization with a history in family planning and reproductive health projects. They gave us invaluable insights into the manufacturing and post-production processes, including packaging and delivery. We got to know about the procedures OviCloak, undergoes before it gets subsidised by the Governmental Organisation or marketed. They raised concern regarding maintaining cold-chain during delivery, as it is a crucial factor during procurement by agencies
Read more on our vision about bringing OviCloak into the real world in Implementation.
Communication
The stakeholder engagement was the inspiration behind our educational activities related to sexual and reproductive well-being.
Meeting Ms Kathy Walkiling was eye-opening as her experience of launching Ecofemme, a menstrual hygiene start-up, made us understand that the stigma surrounding the use of sexual and reproductive health products can be a challenge to implement OviCloak. Thus, we realized the importance of spreading awareness about sexual and reproductive health along with developing a novel contraceptive. This led us to collect data regarding the status of awareness on Reproductive Health and Rights as well as Conducting Sexual and Reproductive Health awareness sessions such as webinars, social media posts and virtual art exhibitions.
We met with Mr Kaustubh Jogelkhar, who is the senior counsellor at an NGO called Pankh that educates young minds about sexual and Reproductive health. The most important takeaway message from him was to deliver the content that fits the short attention span of the current generation. Hence, we explored the possibility of reaching the audience through social media platforms like Instagram reels and Instagram Live sessions.
Ms Sophie Wang, a communicator from the online magazine ‘Biorad’ made us understand the impact of Interactive Zines through her work..This Idea amazed us all, as this perfectly fits into the iGEM’s human practices strategy, setting a two-way dialogue.
Integrated Human Practices Timeline
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References
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- Patiño, R., Bolamba, D., Thomas, P., & Kumakura, N. (2005). Effects of external pH on hormonally regulated ovarian follicle maturation and ovulation in Atlantic croaker.General and comparative endocrinology, 141(2), 126–134. https://doi.org/10.1016/j.ygcen.2004.12.006
- Shi, D., Komatsu, K., Hirao, M., Toyooka, Y., Koyama, H., Tissir, F., ... & Fujimori, T. (2014). Celsr1 is required for the generation of polarity at multiple levels of the mouse oviduct. Development, 141(23), 4558-4568.
- Brantl, S., & Müller, P. (2019). Toxin Antitoxin Systems in Bacillus subtilis. Toxins, 11(5), 262. https://doi.org/10.3390/toxins11050262
- https://live.flatland.agency/12290417/rathenau-igem/