Fertility
Clinical trial of device aims to induce ovulation in women with polycystic ovary syndrome
Physicians are leading a national clinical trial to help women with polycystic ovary syndrome (PCOS)-related infertility who want to become pregnant.
The trial, called REBALANCE, studies the safety and effectiveness of an investigational device developed by May Health that is designed to restore ovulation disrupted by PCOS.
OU Health reproductive endocrinologist Karl Hansen, M.D., Ph.D., chair of the Department of Obstetrics and Gynecology at the OU College of Medicine, is leading the trial for OU and was the first physician in the United States to use the device.
“Polycystic ovary syndrome is a common endocrine disorder that affects about 10% of all women of reproductive age,” said reproductive endocrinologist Karl Hansen at the University of Oklahoma Health Sciences in Oklahoma City .
“And it is the most common cause of infertility related to the absence of ovulation. It is exciting to be studying a new potential treatment option for women with PCOS-related infertility.
“It also highlights the importance of academic medicine. We’re not here to only provide the care that we already know; we’re here to push the envelope and develop new understandings and treatments.”
PCOS is a hormonal imbalance that occurs when the ovaries release an excess of androgens, a sex hormone that plays a central role in reproductive health. The overproduction of androgens sparks a series of events that result in irregular ovulation or the absence of it.
Hansen said about 80 per cent of women with PCOS respond to oral medications designed to stimulate ovulation, and up to 50 per cent of those women will achieve a pregnancy. However, approximately 20 per cent of women do not begin ovulating with the medications.
An alternative treatment involves gonadotropin injections, which require frequent monitoring and precise dosage adjustments. Another option, laparoscopic ovarian drilling, uses a needle-like device inserted through small abdominal incisions to deliver laser or radiofrequency energy to an ovary, aiming to restore ovulation.
However, this procedure has become less common, Hansen said.
The investigational device from May Health aims to prompt ovulation in women with PCOS-related infertility through a minimally invasive outpatient procedure. The device is connected to a probe commonly used in transvaginal ultrasounds, which assesses the ovary before delivering electrothermal energy to perform the appropriate number of ablations on an ovary.
The REBALANCE trial will enrol approximately 195 patients with PCOS-related infertility at multiple sites across the United States.
Researchers will assess how often women ovulate after the procedure. Secondary outcomes that will be measured include the pregnancy rate achieved after the procedure, other symptoms of PCOS, and how long the effects of the procedure endure.
OU Health Sciences is co-leading the trial in conjunction with the University of Pennsylvania.
“We are glad to be partnering with May Health to offer this trial to patients with PCOS-related infertility,” Hansen said.
“Most women with PCOS come to us because they are trying to get pregnant. For the subset of women who do not respond to oral medications, this is an exciting development to evaluate this investigational device.”
AI could transform ovarian care by personalising cancer and fertility treatment, but more clinical validation is needed before routine use.
A systematic review and meta-analysis found AI models showed high diagnostic accuracy for ovarian cancer when combining data such as ultrasound scans and blood test results.
Across 81 studies, AI models correctly identified ovarian cancer in around nine out of 10 cases, with pooled rates of 89 to 94 per cent.
They were also highly accurate at ruling out ovarian cancer when it was not present, with specificity of 85 to 91 per cent.
The analysis also found that explainable AI tools could predict complete surgical cytoreduction in advanced ovarian cancer.
Complete surgical cytoreduction means removing all visible cancer during surgery, which can be an important goal in treatment planning.
The tools achieved a pooled AUC of 0.87. AUC is a measure of how well a model distinguishes between different outcomes, with higher scores showing stronger performance.
In reproductive medicine, AI algorithms helped physicians optimise ovarian stimulation protocols and predict follicular growth during IVF.
Ovarian stimulation is the use of hormones to encourage the ovaries to produce eggs, while follicles are the small sacs in the ovaries where eggs develop.
The review found AI could reliably model ovarian response in IVF with a pooled AUC of 0.81.
However, researchers said challenges remain in translating promising research findings into routine clinical practice.
They identified substantial variation across studies, driven by retrospective study designs, variable AI systems and a lack of standardised validation.
Only 22 per cent of analysed studies reported prospective, multicentre external validation, where models are tested forward in time across multiple healthcare settings.
The authors called for rigorous validation to help close the gap between research and routine clinical practice, alongside standardised methodological and reporting frameworks, smooth integration with clinical workflow and robust governance to support responsible and ethical AI use.
They concluded: “Artificial intelligence is a transformative force in the management of ovarian conditions.
“In gynaecologic oncology, AI enhances every phase of care, from early detection and accurate diagnosis to prognostic stratification and surgical planning.”
In reproductive medicine, AI personalises ovarian stimulation and refines the diagnosis of heterogenous endocrine disorders such as PCOS.
PCOS, or polycystic ovary syndrome, is a hormonal condition that can affect periods, skin, weight and fertility.
Housing, work and fertility pressures are stopping many Britons growing the families they want, new research suggests.
A UK fertility report found that 79 per cent of people surveyed who had tried to conceive in the past five years would like more children than they currently have.
Among parents with one child, that figure rises to 88 per cent.
The report surveyed more than 1,000 people across the UK who had tried for a baby in the past five years.
While birth rates continue to fall, the findings suggest it is not because people no longer want children. Instead, many respondents said external pressures are making it harder to grow their families.
The findings, from wellness brand Wild Nutrition’s Fertility Disconnect report, highlight how financial pressures, fertility struggles and gaps in reproductive health knowledge are shaping modern family life in the UK.
Gail Madalena, fertility nutritional therapist at Wild Nutrition, said: “People often assume fertility begins the moment they decide to try [for a baby].
“In reality, egg and sperm health are shaped months and years earlier.
“By the time someone starts thinking about fertility, their body has already been responding to its environment for a long time.”
Among the biggest barriers, 26 per cent said career progression affected their family plans, 25 per cent cited housing affordability and lack of space, and 52 per cent said they required medical intervention during their fertility journey.
The report also found that almost a quarter of respondents had spent more than two years trying to conceive.
Trying for a baby can take a significant toll on mental health and relationships, especially for those navigating fertility treatment.
According to the research, 38 per cent of respondents said trying to conceive had negatively affected their mental health. That figure rose to 99 per cent among people undergoing fertility treatment.
Julianne Boutaleb is a perinatal psychologist.
She said: “Navigating a fertility journey is about so much more than medical appointments and procedures.
“It’s an emotional marathon that can take a huge toll on your mental wellbeing.
“Sadly, the stats show that 15 per cent of couples going through fertility treatment say their relationship has been irrevocably impaired.”
The report also highlighted the realities of secondary infertility, which affects around one in 20 people, challenging the assumption that having one child means conceiving again will be straightforward.
Researchers found many people felt under-informed about fertility, particularly younger adults.
Ten per cent of Gen Z respondents said they “know nothing” about fertility, while only one in five respondents said they know “a lot” about egg health.
The report also found that 60 per cent of women were unaware of fertility testing options, and one in five Gen Z respondents said they felt uncomfortable discussing fertility, even with their partner.
Around 40 per cent of those surveyed supported fertility education being included in schools, covering topics such as egg health, sperm health and hormonal health.
The report also explored how lifestyle and long-term health may influence fertility outcomes.
Many respondents said they only made changes once they started trying to conceive.
Some 44 per cent improved their diet when trying for a baby, while 32 per cent reduced alcohol intake at that stage.
The report also referenced emerging research that suggests ultra-processed foods and microplastics could have an impact on reproductive health.
While fertility conversations often focus on women, the findings showed male fertility issues are also affecting many families.
Seventeen per cent of respondents cited sperm health issues as a barrier to conception, while male factors contribute to around half of all fertility challenges.
Only one in four men said they would share fertility struggles with friends.
“Many causes of male infertility are entirely treatable yet so often the last resort is the first response,” said Ian Stones, co-founder at Test Him Ltd.
The findings come as UK birth rates remain below replacement level.
The report noted that the UK fertility rate is now 1.41, meaning that on average women give birth to 1.41 children over their lifetimes. The replacement rate, or rate that maintains population numbers, is 2.1.
It also said the average age of mothers has risen to 31, while birth rates are falling across most age groups except among over-40s.
“There is no single fertility story, and it is rarely a simple, linear narrative,” said Dr Zeynep Gurtin, lecturer in women’s health at UCL.
Dr Gurtin added that better fertility education, fairer access to treatment and more open conversations around infertility and pregnancy loss are needed.
Femtech World is thrilled to reveal the shortlist for the Fertility Innovation Award.
The award, sponsored by FinDBest IVF, celebrates a pioneering product, service or initiative that is transforming fertility care and support.
FinDBest IVF is a global B2B digital platform created to simplify and accelerate how IVF and ART manufacturers connect with trusted, pre-vetted distributors around the world.
This year’s nominees represent a remarkable breadth of approaches to fertility care: from clinic-floor breakthroughs to at-home hormone intelligence to truly borderless access.
Three companies made the cut, with each tackling a real, persistent barrier in reproductive health.
Congratulations to the shortlist and many thanks to everyone who entered.
Fertility Innovation Award Shortlist
HRC Fertility’s Needle-Free IVF is a pioneering advancement designed to transform one of the most challenging aspects of fertility treatment: daily hormone injections.
Developed by board-certified reproductive endocrinologist Dr Rachel Mandelbaum, this innovative approach reimagines how stimulation medications are delivered during IVF and egg freezing, dramatically improving the patient experience while maintaining the same trusted clinical outcomes.
Inspired by feedback from patients who struggled with the injection process, Dr Mandelbaum adapted an innovative drug-delivery system commonly used in other areas of medicine and applied it to reproductive care
Mira is a hormonal health technology company that provides lab-grade hormone testing and AI-driven insights to help women and couples understand their fertility.
The platform has already supported more than 200,000 couples on their fertility journeys worldwide, helping over 60,000+ users achieve pregnancy.
For some users, pregnancy rates have reached up to 89 per cent within six months, demonstrating how accurate hormone data can significantly improve fertility outcomes.
Founded in 2021 by Marija Skujina, a Certified Fertility Nurse Specialist accredited by the European Society of Human Reproduction and Embryology, with nearly 15 years of clinical experience at one of the world’s top IVF clinics, and having navigated her own fertility journey as a patient, Marija built the clinic she had always wished existed.
Plan Your Baby began with a bold, but simple mission – make best quality fertility and pregnancy available anywhere.
Plan Your Baby has created a new generation fertility and pregnancy clinic with patients accessing expert consultations remotely, while blood tests and ultrasound scans are available at over 450 locations across the UK, eliminating the exhausting travel burden that often forces people to take days off work, relocate appointments, or abandon treatment altogether
What happens now
The shortlist will be judged by a representative from category sponsor FindBestIVF, with the winner announced at a virtual event on June 19.
Winners will receive a trophy and be interviewed by a Femtech World journalist.
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