Determine your most fertile days at home

Elleloom from a Medical Perspective

27th of March 2024. Dr. Bernhard Klaassen

Introduction

Elleloom is a new and innovative way to determine when a woman is fertile. Identifying fertile days can now be done much more easily and accurately than with traditional methods available in the market for individuals. Good news for women trying to conceive!

Elleloom consists of a speculum called Femiscope®, a camera, and an app. The Femiscope is a woman-friendly version of the traditional speculum. With these tools, the so-called pupil sign on the cervix can be observed. The app provides insight into the time window during which ovulation occurs. This method reveals the two most fertile days of the month, which is much more accurate than other available methods.

This innovation does not conflict with medical guidelines and has no adverse consequences for medical policies and actions regarding the implementation of medical standards and guidelines. On the contrary, it helps in following a medically indicated wait-and-see approach, where the woman can responsibly shorten her time to pregnancy.

Elleloom is a modern, woman-friendly self-care product for women wishing to conceive, providing
anonymous and private information about fertile hours and days without complicated and hard-to-
interpret hormone measurements in blood or urine. The instrument has been conceived and developed by the medical profession.

Problem statement

Detecting, guiding, and treating subfertility costs enormous amounts of money and demands vast
training capacities for doctors and laboratory staff. About one in six couples face subfertility. Each year, around 50,000 couples visit their general practioner, and about 30,000 couples seek specialist care (*1). Research shows that many referrals and treatments are unnecessary: 36% of women in treatment are treated without medical benefit (*2). New strategies have been devised to solve this problem, but fertility specialists and general practioners have been unable to resolve it on their own (*3).

The application of digitization, artificial intelligence, telehealth, and telecommunication hasbecome indispensable for keeping healthcare accessible, affordable, and improving it. The use of the zero line of care aligns with democratization in healthcare delivery, contributing to cost control, preventing early referrals, and helping doctors better adhere to guidelines.

Self-care in subfertility, family planning, or unfulfilled childbearing desires can be an alternative without violating the existing guidelines for healthcare professionals. It can also be recommended for women to follow a wait-and-see approach, but they can also be made aware of the possibility to naturally shorten their time to conception. This is achievable using the NFP method and the "fertile window." This method has been evaluated in Germany (*4) and has proven very successful.

This process is now possible with Elleloom, without the need for training, and is automated so that no medical assistance is required for women to become pregnant as quickly as possible. This method can coexist alongside the standards and serves as a solution for women who, according to the standards, should have received a wait-and-see approach but were nevertheless referred.

Elleloom

Elleloom contributes to making healthcare more affordable and prevents unnecessary costs. A Belgian professor played an enormously important role as a specialist. In 2005, the Femiscope® was noticed as a smart speculum by Prof. Brosens (professor emeritus in Leuven, Belgium). He reversed the NFP contraceptive method to identify the best time for conception, i.e., ovulation. He had women use the Femiscope® at home to conduct self-examinations and visually identify the most fertile hours in the cycle, known as the "fertile window." The predictive value of these hours, the fertile window, is two to four days. This period is shorter than that of hormonal measurements (ovulation predictor kits, OPKs), which cover six days. His research led to a scientific publication in the U.S. (*5).

This publication resulted in a redesign of the Femiscope as part of the self-care product, Elleloom. The final steps followed, incorporating a camera and automating observations and analysis. The best moment for conception is now made visible and explained to the woman through the so_ware. She does not need to conduct any analysis herself, nor does she need medical knowledge. She can capture an image herself and send it for evaluation. The evaluation is fully automated, based on digital data analysis.

Product information for Doctors

Elleloom consists of an innovative speculum that is medically certified and therefore can be used both intramurally and extramurally. A digital camera is connected on one side to a mobile device, such as a smartphone or laptop, and the camera is placed inside the innovative speculum. The personal so_ware, licensed to a single woman, creates a secure connection via the internet to a secure website for analyzing the images of the cervix. The evaluation is automated, without human interpretation, using AI.

The innovative technology is comparable to laparoscopy (quote by Dr. Maarten Wiegerinck,
gynecologist). The photos and videos made can be used for teleconsultation and information exchange within the medical profession itself or inter-disciplinarily between the third, second, and first lines of care, as well as with the zero line.

Elleloom as a Self-Care Product

Elleloom offers women the opportunity to inspect the cervix uteri during the cycle. The ectocervix and mucus are automatically analyzed by the software. The optimal moment during the fertile days is characterized by the maximal opening of the cervix with mucus present. Studies have shown that women can detect the best time for conception themselves through self-examination with Elleloom, supported by AI-based software. During ovulation (in a fertile cycle), the cervix has fully transformed to allow semen to enter.

Existing Guidelines Remain Unchanged

The existing guidelines remain the medical standard. Self-care does not change that. Referring to self-care as an alternative is now an option when there is no indication for examination, treatment, referral, or intervention. This will be evident if the guidelines are followed closely.

The National Network Guideline for Subfertility is an extensive guideline for all disciplines dealing with subfertility problems; see Subfertiliteit-landelijke-netwerkrichtlijn.

General practitioners can quickly orient themselves to the necessary steps with the NHG standard for subfertility. Hard referral criteria are described here; see Subfertiliteit.

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