Differential gene expression in peripheral blood mononuclear cells (PBMC) from healthy women during the normal menstrual cycle compared to women in menopause and healthy men.

• Conditions: Immune system; The normal menstrual cycle; Menopause; Inflammatory and Immune System - Normal development and function of the immune system; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12619000049178
• Lead Sponsor: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-15
• Last Update Posted: 28 January 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified