None listed
Conditions
Brief summary
The aim of this study is to determine the effects of the ovarian cycle on the whole genome transcriptome by microarrays in blood peripheral mononuclear cells (BPMC) from healthy menstruating (in the three different phases of the menstrual cycle), postmenopausal women and normal adult men to explain the differences in immunological responses existing between women and men.
Interventions
This study will take place in the Reproductive Health Clinic of the Reproductive Biology Department Dr. Carlos Gual Castro at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (Mexico City). Daily, the investigators will check the clinical electronic records of healthy men and women assisting to the Family Planning Clinic for interview and possible recruitment, as well as, those corresponding to menopausal women assisting to Reproductive Endocrinology Clinic. The selected subjects will be invited to participate in the study after explaining all the details and procedures that will be done in this study. The study protocol was approved by the Human Research and Ethical Committee of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, and all participants will sign an informed consent form. Study subjects selection and study Groups Thirty volunteer subjects without history of hormonal or any other medication, including glucocorticoids within six months before the study will be recruited and studied as follows: twenty women divided in two Groups; Group I: 10 normally ovulatory women and Group II: 10 postmenopausal women and Group III: 10 normal adult men. Those subjects in Group I will be followed longitudinally along the menstrual cycle for blood sampling (30 ml) taken as follows, days 1 to 5 (early follicular), days 10–12 (late follicular) and days 21–23 (mid-luteal) taking as day one the first day of bleeding. In the case of Groups II and III, subjects will be studied at similar time intervals. In all subjects, the blood samples will be drawn from the antecubital vein, after a 10–12 hour overnight fast (nil by mouth), between 08:00 and 09:00 h. In all subjects a medical history, physical examination, and routine screening laboratory analysis will be obtained in order to ensure good health conditions.
Sponsors
Eligibility
Inclusion criteria
Group I: -Healthy ovulatory women. -Age: 18 to 35 years old. -Body mass index (BMI): 18-27.5 kg/m2. -Regular menstrual cycles between 28 to 30 days of duration. -At least 6 months postpartum or abortion. -Normal basal hemoglobin. -Availability to come to all visits. -Acceptance to participate in this study voluntarily. -Informed consent signed. Group II: -Healthy women in menopause. -Age: greater than or equal to 50 years old. -Body mass index (BMI): 18-27.5 kg/m2 -Normal basal hemoglobin. -Availability to come to all visits. -Acceptance to participate in this study voluntarily. -Informed consent signed. Group III: -Healthy adult men. - Age: 18 to 35 years old. -Body mass index (BMI): 18-27.5 kg/m2 -Normal basal hemoglobin. -Availability to come to all visits. -Acceptance to participate in this study voluntarily. -Informed consent signed.
Exclusion criteria
Group I: Healthy ovulatory women. - Pregnancy suspected or confirmed. - Gynecologic neoplasia. - Abnormal uterine bleeding. - Pathological galactorrhea. - Pelvic inflammatory disease. - Immune-type disease. - Changes over 3% of the BMI registered in the first visit during the study period. - Endocrine diseases or degenerative as diabetes mellitus, hypertension, neoplasia, deep venous thrombosis, cardiovascular disease, hepatic or kidney injury (accute or chronic). - Use of hormonal contraceptives, glucocorticoids, antidepressants, antiretroviral, immunemodulators or immunesuppressants, antibiotics or another treatment that could interfere with the activities of innate or acquired immunity. - Infectious process in the last three weeks. - Participation in another project that could interfere with the present study. Group II: Healthy women in menopause. - Gynecologic neoplasia. - Postmenopausal uterine bleeding. - Immune-type disease. - Pathological galactorrhea. - Use of hormonal therapy. - Endocrine diseases or degenerative as diabetes mellitus, hypertension, neoplasia, deep venous thrombosis, cardiovascular disease, hepatic or kidney injury (accute or chronic). - Use of hormonal therapy, glucocorticoids, antidepressants, antiretroviral, immunemodulators or immunesuppressants, antibiotics or another treatment that could interfere with the activities of innate or acquired immunity. - Infectious process in the last three weeks. - Participation in another project that could interfere with the present study. Group III: Healthy adult men. - Testicular or prostatic neoplasia. - Pathological galactorrhea. - Immune-type disease. - Endocrine diseases or degenerative as diabetes mellitus, hypertension, neoplasia, deep venous thrombosis, cardiovascular disease, hepatic or kidney injury (accute or chronic). - Use of hormonal therapy (exogenous androgens or treatment to induce spermatogenesis), glucocorticoids, antidepressants, antiretroviral, immunemodulators or immunesuppressants, antibiotics or another treatment that could interfere with the activities of innate or acquired immunity. - Infectious process in the last three weeks. - Participation in another project that could interfere with the present study.