Women Who Have Recurrent Miscarriages Could One Day Be Treated Using Diabetes Drug

Scientists hope a drug currently used to treat diabetes could prevent miscarriages in women.

Researchers recruited 33 women aged between 18 to 42, who had experienced at least three unexplained miscarriages, for the pilot clinical trial. They asked them to either take the diabetes drug sitagliptin or a placebo for three menstrual cycles.

At the end of the study, eight women who took sitagliptin had babies, one fell pregnant but had to terminate due to a fetal abnormality, and three lost their pregnancies before 12 weeks of gestation. The patients didn't experience any serious side-effects. Among participants who took the placebo, seven gave birth, and six lost their pregnancies before 12 weeks.

The team found the drug had changed the lining of the woman's womb in a way that appeared to create the right environment to support pregnancy. They published their findings in the journal EBioMedicine.

Co-author professor Jan Brosens of the U.K.'s Warwick Medical School told Newsweek of the steps that lead his team to carry out the pilot trial. Previously, the entrenched view among clinicians was that early pregnancy is a "fragile" state that can be disrupted by a host of sub-clinical disorders. It was thought restoring the balance would result in pregnancy. "Unfortunately, there is no evidence that this approach actually works," he said.

A decade ago, his team made a discovery about special cells in the lining of the womb that surround the implanting embryo. What are known as "decidual" cells get rid of poor quality embryos and support the development of high-quality embryos, Brosens explained.

"In other words, we had discovered that there was an implantation 'checkpoint,' which limits prolonged maternal investment in invasive but abnormal embryos," he said.

The team later hypothesized that women suffering from recurrent pregnancy loss experienced more failures in this checkpoint process than others, which could be explained by a lack of what are known as endometrial stem cells, or those that line the uterus. This caused the decidual cells to become inflamed and create a situation where the lining of the womb broke down, he said. Brosens' team wondered whether a drug that works on endometrial stem cells could help women who have miscarriages.

Women who took sitagliptin for three menstrual cycles had a significant increase in their endometrial stem cells compared with those who took the placebo. There was also a "dramatic decrease" in the abundance of stressed inflammatory decidual cells, Brosens said.

"Participants who were treated with sitagliptin did very well in their subsequent pregnancy," he said. "However, our study was designed to assess the effect of the drug on endometrial stem cells and [was] not large enough to draw meaningful conclusions on the miscarriage rate in subsequent pregnancies. Thus, a larger clinical trial is needed before this treatment can be introduced into clinical practice."

If the follow-up clinical trial is a success "there should be very few hurdles to adopt this treatment worldwide," said Brosens.

Experts not involved in the research said the findings were promising. Andrew Shennan, professor of obstetrics King's College London, said the study was well-conducted and the results "exciting."

However, he noted the small number of women who took part don't represent most women who lose pregnancies, as they were at very high risk of recurrent miscarriages.

"This drug would not benefit most women with miscarriages but could be promising for those with many losses due to a specific problem of hostile response to the baby that occurs in a few women. It does need more women to be studied but looks promising, said Shennan.

Dr. Jane Stewart, the chair of the British Fertility Society, called the research "excellent" in a statement.

"For patients, the lack of treatment to prevent recurrent miscarriage is frustrating," she said. "The clinical trial planned to test this repurposed drug will be important— the promise of a treatment for miscarriage based on solid fundamental science deserves a large and effective clinical trial. As a clinician, I hope that my patients will be involved, and it would be great if colleagues follow suit."

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