Reproductive Endocrinology & Infertility

KEEPs

While multiple observational studies and meta-analysis have consistently shown a protective effect of Menopausal Hormone Therapy (MHT) on cardiovascular disease, recent randomized controlled trials, such as the Heart and Estrogen/progestin Replacement Study (HERS) and the Women’s Health Initiative (WHI), have clearly shown that MHT does not reduce cardiovascular disease, and may induce “early harm” in some women. This inconsistency cannot be explained by supposing that the observational trials were incorrect because of biases. The KEEPS study seeks to assess, in a randomized, double-blind, multi-center trial of young symptomatic women, whether oral or transdermal estrogen reduces atherosclerosis as compared to placebo over four years. Because young women have very few coronary events, carotid intra-medial thickness (IMT) and coronary calcium (EBT) will be the major endpoints; other surrogate markers will also be assessed.

Cinnamon

Polycystic ovary syndrome (PCOS) is one of the most common endocrine gland disorders among women of reproductive age. Its impact on women’s health is profound, as it is associated with diabetes mellitus, dyslipidemia, cardiovascular disease, obesity, endometrial hyperplasia or cancer, menstrual irregularity, and infertility. Recent research has implicated the pathogenic role of insulin resistance and compensatory hyperinsulinemia in the impediment of ovulation and in the development hyperandrogenism. Growing evidence indicates that high insulin levels mediate increased ovarian androgen production, resulting in anovulation and infertility. Agents improving insulin resistance, and therefore reducing hyperinsulinemia, theoretically may result in reduced ovarian and serum androgen levels. Cinnamon has been found to have insulin-sensitizing effects in both animal and human studies; our own prospective randomized, placebo-controlled pilot study involving 15 women with PCOS demonstrated significant reductions in fasting glucose and insulin-resistance parameters after eight weeks of oral cinnamon extract. However, the short duration of treatment and small sample size precluded us from evaluating clinical outcomes. The primary purpose of this follow-up study is to determine if cinnamon can restore menstrual cyclicity in PCOS subjects with oligomenorrhea. We also intend to confirm the salutary effect of cinnamon on insulin resistance in a larger group of study subjects. The primary outcome of our study will be the number of menses during the six-month study period.

Seprafilm Slurry

Scar tissue within the uterus is one of the major complications of uterine surgery. Previous studies have estimated the incidence of these adhesions after the removal of fibroids at anywhere between 30%-50%, depending on the type of surgical technique and the fibroids’ severity. To date, there is no recommended way to prevent this outcome; many physicians have experimented with antibiotics, hormone replacement therapy, and other devices to hold the uterus open, to no avail. Seprafilm is an FDA-approved temporary bioresorbable barrier that physically separates opposing tissue surfaces. The physical presence of the membrane separates adhesiogenic tissue while the normal tissue repair process takes place. When used in the abdominopelvic cavity, it has been shown to reduce the incidence of adhesions. This study will examine whether, by placing a slurry of Seprafilm in the intrauterine cavity and creating a temporary physical barrier between the walls of the uterus, we will be able to prevent iatrogenic intrauterine adhesions. Given that an increasing number of women are delaying their child-bearing years, which is associated with an age-related increased risk of infertility secondary to fibroids, this study is of great clinical importance at present.