Uterine Environment Study
The Impact Of Maternal Health On Uterine Cellular And Molecular Environment
The interior of the uterus is lined with a tissue called endometrium. This tissue is necessary for a pregnancy to develop. If a pregnancy is present or does not develop, the endometrial lining is shed and menstruation occurs. Problems with the endometrium can cause infertility and/or early miscarriage in women. If pregnancy does occur, changes in the endometrial lining prior to pregnancy may impact the development of the placenta—the organ that provides oxygen and nutrients to a growing baby—and can affect the growth and well-being of a developing baby. The purpose of this study is to evaluate the effect of the maternal characteristics, environment and fertility treatments on the endometrium. We are examining the effect of age, body weight, infertility and hormonal status (your own hormones, as well as those used for fertility) on the endometrium. We are studying how these conditions change the different cells that are in the endometrium including the bacteria that live in the vagina, cervix and uterus.
For this study, we are asking women to allow us to obtain a swab from the vagina, cervix and endometrium as well as small sample of tissue from the lining of the uterus. This sample is called an endometrial biopsy. We will look at this tissue and examine the composition of cells and other characteristics of this tissue.
We will also be obtaining a blood sample (approximately 1 teaspoon) at the time(s) we obtain the swabs and endometrial biopsy. We will perform the same tests on the blood sample described above on the endometrial biopsy. Four groups of women will be included in this study.
Group A is comprised of women who are undergoing IVF but not having an embryo transferred.
Group B and C are comprised of women who are not attempting pregnancy or being treated with fertility drugs.
Group D is comprised of women who are being treated for infertility but are not being treated with fertility drugs during the current menstrual cycle.
Additional Information About The Study:
You will receive $200 following each clinical visit (at which time vaginal, cervical, and endometrial sampling will be performed) as compensation for your time and travel expenses. If you complete two clinical visits your total compensation will be $400.
Please contact Anna Sokalska MD, PhD (firstname.lastname@example.org), phone 267-586-8311, if you are interested in the study or have any additional questions.
Monica Mainigi, MD
Kathleen O’Neill, MD, MTR