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Clinical trial of device aims to induce ovulation in women with polycystic ovary syndrome

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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.”

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Covid vaccine not linked to decrease in childbirth, study finds

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The Covid vaccine is not behind a fall in childbirth, a Swedish study has shown.

Rumours on social media have alleged that the jab impairs chances of becoming pregnant.

In the later stages of the pandemic, some countries, including Sweden, saw fewer births, raising the question of whether vaccines were responsible.

The study analysed all women aged 18 to 45 years in Region Jönköping County, Sweden, a total of almost 60,000 women. Of these, 75 per cent were vaccinated once or more against Covid-19 from 2021 to 2024.

Researchers at Linköping University used healthcare records on childbirths, miscarriages and deaths.

Comparing vaccinated and unvaccinated groups, the researchers found no statistically significant differences in childbirths or miscarriages.

This aligns with previous studies finding no link between the Covid vaccine and fertility.

 Toomas Timpka is professor of social medicine at Linköping University.

Timpka said: “We see no difference in childbirth rates between those who have taken the vaccine and those who haven’t.

“We’ve also looked at all registered miscarriages among those who became pregnant, and we see no difference between the groups there either.

“Our conclusion is that it’s highly unlikely that the mRNA vaccine against COVID-19 was behind the decrease in childbirth during the pandemic.”

The researchers suggest other explanations for the dip in births.

People now in their 30s were born in the late 1990s, a period of economic strain and lower birth rates in Sweden, shrinking today’s cohort of potential parents.

Additional pandemic-related factors, such as health and economic concerns and changed behaviour during lockdown, may also have reduced childbirth.

A strength of the study is its large, nationally representative cohort.

The analysis adjusted for age to avoid masking any potential vaccine effect on childbirth.

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Parents sue IVF clinic after delivering someone else’s baby

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A Florida couple have sued an IVF clinic after giving birth to a baby who is not genetically related to either of them.

Tiffany Score and Steven Mills hired IVF Life, which operates as the Fertility Center of Orlando in Longwood to help them conceive about five years ago using in vitro fertilisation.

The couple had an embryo implanted in April and welcomed a baby girl nine months later, but soon suspected the clinic had made an error.

Both Score and Mills are white, but the baby had the appearance of a racially non-Caucasian child, according to the lawsuit.

Genetic testing confirmed that the baby is not biologically theirs. The couple filed the lawsuit on 22 January after allegedly trying to contact the clinic multiple times without getting a response.

Jack Scarola, one of the couple’s lawyers, told the Orlando Sentinel: “They have fallen in love with this child. They would be thrilled in the knowledge that they could raise this child.

“But their concern is that this is someone else’s child, and someone could show up at any time and claim the baby and take that baby away from them.”

Score and Mills are also concerned that one of the three fertilised eggs they had frozen at the clinic may have been mistakenly implanted into someone else.

They have demanded that the clinic share what happened with all other patients who had embryos stored at the facility during the year before Score gave birth. They also want IVF Life to pay for genetic testing of every child born as a result of its services over the last five years, and to account for their remaining embryos.

The couple said in a statement: “We love our little girl. We would hope to be able to continue to raise her ourselves with confidence that she won’t be taken away from us.

“At the same time, we are aware that we have a moral obligation to find and notify her biological parents, as it is in her best interest that her genetic parents are provided the option to raise her as their own.”

A family spokesperson said: “Based upon leads discovered to date, and despite the lack of help or cooperation from the clinic, there is hope that we will be able to introduce our daughter to her genetic parents and to find our own genetic child soon.”

The lawsuit names IVF Life LLC and Dr Milton McNichol, who runs the clinic.

The Fertility Center of Orlando had posted a notice on its website stating it is “actively cooperating with an investigation to support one of our patients in determining the source of an error that resulted in the birth of a child who is not genetically related to them.”

The notice was removed after a court hearing on Wednesday.

During the hearing, the judge ordered the clinic to submit a thorough plan for handling the situation by Friday.

McNichol was reprimanded by Florida’s Board of Medicine in May 2024 after an inspection of the clinic in June 2023 revealed several issues, including equipment that did not meet current performance standards, failure to comply with a risk-management plan and missing medication.

He was fined US$5,000.

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Fertility

Femtech World Awards to celebrate breakthrough fertility innovations

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Fertility innovation is to set to take centre stage at Femtech World’s third annual awards event.

The Femtech World Awards will celebrate some of the best examples of leadership, innovation and impact in key areas that affect women’s health and wellbeing.

The Fertility Innovation of the Year award celebrates a pioneering product, service or initiative that is transforming fertility care and support.

The winner will have demonstrated exceptional innovation in helping individuals or couples navigate fertility journeys, whether through technology, treatments, education, accessibility, or emotional support.

Consideration will be given to scientific advancement, inclusivity, user impact and the ability to break barriers in fertility health.

The award is sponsored by FinDBest IVF – a global B2B digital platform created to simplify and accelerate how IVF and ART manufacturers connect with trusted, pre-vetted distributors around the world.

Launched in 2024, the platform addresses a long-standing challenge in the MedTech sector—fragmented, costly, and inefficient market access—by offering a curated, country-specific directory of active partners, complete with key segmentation, certification indicators, and direct contact tools.

From consumables and lab equipment to AI-powered embryo selection and genetic testing solutions, FinDBest makes it faster and easier for companies to scale internationally—without relying on expensive congresses or cold outreach.

Juan A. Jiménez is founder and CEO of FinDBest IVF.

He said: “As part of its commitment to driving smarter access to reproductive innovation, FinDBest IVF is proudly supporting the Femtech World Fertility Innovation Awards for the second year in a row.

“This collaboration reflects two core beliefs at the heart of the platform.

“First, FinDBest IVF was created to accelerate not only the discovery of innovative fertility solutions but their global adoption.

“By supporting these awards, the platform helps amplify breakthrough technologies—from AI-based egg quality tools to next-gen IVF microdevices—and ensures they can reach the right partners and clinics faster.

“Second, the Awards align with FinDBest’s vision of building a 360-degree commercialisation ecosystem, where innovation is not just recognised, but connected to real-world opportunities.

“Many award nominees are pioneering startups and clinical researchers—exactly the kind of innovators who benefit from FinDBest’s support in navigating regulatory complexity, distributor validation, and go-to-market strategies across diverse regions.

“Together with Femtech World, FinDBest IVF is helping to spotlight, support, and scale the future of fertility care.”

Find out more about the Femtech World Awards and enter for free here.

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