DETROIT – A standard treatment to help women with fertility issues get pregnant may do the exact opposite, according to a study led by Wayne State University School of Medicine Professor Michael Diamond, M.D.
The results revealed that women with polycystic ovary syndrome (PCOS) treated with the hormone progestin are four times less likely to conceive than those who don’t take it.
“The results were very much a surprise,” said Dr. Diamond, the Kamran S. Moghissi Professor of Obstetrics and Gynecology and associate chair of the school’s Department of Obstetrics and Gynecology.
Dr. Diamond estimates that 10 percent of infertility clinic patients nationally have PCOS.
“It makes me realize that we need to continue to study and learn and identify ways to help these couples,” he said.
The hormone progestin is often given as a first step in infertility treatment for PCOS. Researchers at 16 sites within the National Institutes of Health’s (NIH) Cooperative Reproductive Medicine Network, including WSU, analyzed data originally captured in 2007 on 626 women who underwent 2,809 cycles in which they were trying to conceive. Twenty percent of those who did not receive progestin conceived – 15 percent more than those who did.
The study was co-conducted by Dr. Diamond and Richard S. Legro, M.D. of the Penn State College of Medicine, and was published recently as the lead article in Obstetrics and Gynecology, the official publication of the American College of Obstetricians and Gynecologists. The study was accompanied by a journal editorial and physician-led online blog.
The 2007 RMN study compared three fertility treatments for women with PCOS: the standard drug therapy clomiphene, which stimulates ovulation, the diabetes treatment drug metformin, and a combination of both.
“If we looked at the entire study population or any one of three subgroups, they had a marked reduction in their likelihood of conceiving, as well as having a live birth,” Dr. Diamond said. “(Administering progestin) will now, I’m sure, be a question in everyone’s mind. I would want to see the appropriately powered study conducted and completed confirming these preliminary results before altering recommendations for clinical care, even though they are strong and compelling.”
These findings have implications for clinical care if they can be confirmed, and a follow up study is needed, he added.
The research team, which includes WSU’s Elizabeth Puscheck, M.D., M.S., chair and professor in the Department of Obstetrics and Gynecology, will apply for funding from NIH this month. A study will take a few years, but the results could change textbooks, rewrite medical society recommendations, policy and more, Dr. Diamond said.
The NIH defines PCOS as a disorder in which the ovaries, and sometimes the adrenal glands, produce excess amounts of hormones known as androgens. According to the NIH, women with PCOS typically have menstrual irregularities and may have difficulty getting pregnant.
Infertility treatment for the condition typically involves ovulation induction – drug treatment to stimulate the release of an egg. Before ovulation induction, physicians may administer a single course of progestin. Progestin leads to a thickening in the lining of the uterus. Without continuous administration of progestin to maintain the thickening, the uterine lining is sloughed off, and bleeding begins. The idea behind the treatment is to simulate the bleeding that occurs at the beginning of the monthly menstrual cycle.
Women with PCOS frequently experience insulin resistance, a condition in which the body fails to use insulin properly. Studies have shown that drugs such as metformin, which make the body more sensitive to insulin, can increase ovulation rates in women with PCOS. However, the 2007 study found that women taking metformin alone were less likely to get pregnant and give birth than those receiving either clomiphene or a combination of clomiphene and metformin.
The current analysis of the data from the 2007 study compared the effectiveness of ovulation induction combined with advance progestin treatment to that of ovulation induction alone. The analysis revealed that when women had a spontaneous menstrual cycle, 72 percent ovulated again the following month. About 5 percent of these women were able to conceive.
However, many of the women pursuing fertility treatment failed to ovulate in a given month. Women who received a dose of progestin, followed by ovulation induction, ovulated in 30 percent of cases. Nearly 7 percent of these women conceived.
Women who did not receive progestin ovulated 27 percent of the time, but nearly 28 percent of these women were able to get pregnant.
The study authors noted that simulating the menstrual cycle is also used in infertility treatments for other kinds of infertility.
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