Infertility affects approximately one in six couples and is one of the top causes of psychological stress, on par with non-reproductive diseases like cancer. But with a grant from the National Institutes of Health, Yale researchers may be able to help combat it.
The NIH has awarded $12.4 million to a team of Yale scientists to oversee the collection of data on the causes and treatments of infertility and other reproductive diseases and disorders.
The researchers, headed by Heping Zhang, professor of biostatistics and director of the Yale Collaborative Center for Statistics in Science, make up the Data Coordinating Center as part of the NIH’s Reproductive Medicine Network.
They will oversee a network of seven other clinical centers to monitor study design, data management and analysis.
Zhang is currently meeting with RMN’s Steering Committee in Washington, D.C., to determine network protocols and the exact treatments to be investigated.
After spending most of his career studying child health, Zhang said infertility has a myriad of issues associated with it, including its expense, inconvenience and psychological effects.
“For people who want to have children and cannot, infertility is a very significant social and public-health issue,” said Zhang.
The team will scrutinize various study proposals and collaborate with the NIH to determine which ones will be sponsored by the grant.
Once the studies have been chosen, the team will examine the studies to ensure that they are consistent and follow protocol, said Lawrence Scahill, a member of the team and a professor at the School of Nursing.
Scahill was asked to join the committee because of his experience conducting multi-site clinical trials in the field of child psychiatry. He said such studies require specific considerations, such as monitoring quality, aligning with protocol and ensuring that procedural systems are in place to collect and enter data.
“Multi-site trials are a big, expensive undertaking, and it would be a shame to invest a lot of money in a major clinical trial and not having findings because things weren’t done right,” he said. “So it makes sense to bring together people with different expertise so they can collaborate to have the best chance of having useful results.”
The committee also brings together other scientists from different specialties and areas of expertise, including Robert Makuch, a professor of biostatistics at the Yale School of Public Health, and Hugh Taylor and Pasquale Patrizio, both of the Yale Fertility Center.
Patrizio, who will provide clinical and scientific expertise, said he thinks the network will help scientists pursue new avenues to understanding the causes of and treatments for infertility.
He said the committee will help them better understand and more confidently interpret the data collected.
“[The NIH] has to have somebody that is out of the network to critically analyze the study and data,” Patrizio said.
The RMN, established in 1989, is restructured every five years, when new centers apply to participate.
Yale applied one year ago to be the Data Coordinating Center, with a detailed plan for how the team would oversee the clinical studies, according to Zhang’s grant proposal.
This is the second time Zhang has participated in an NIH reproductive-studies network. He previously received federal funding to coordinate the National Genomic and Proteomic Network for Preterm Birth Research.
In addition to Yale, seven other universities — including the University of Pennsylvania, the University of Michigan and the University of Colorado — are members of the NIH network.