Body Fat As Determinant of Female Gonadal Dysfunction

Launched by FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO RAMON Y CAJAL · Feb 12, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how body fat affects women's reproductive health, particularly in conditions like Polycystic Ovary Syndrome (PCOS) and hypothalamic amenorrhea, where menstrual cycles are disrupted. The researchers believe that the amount, distribution, and function of body fat may play a role in these conditions. They will examine five different groups of women, including those who exercise a lot but have missed periods, women with different types of PCOS, and healthy women, to better understand how body fat and muscle communicate with the reproductive system.

To participate in the study, women should be between 18.5 and 40.0 in body mass index (BMI) and meet specific criteria based on their reproductive health and lifestyle. Participants can expect to undergo tests related to their body fat, hormone levels, and overall health. This research aims to uncover new insights into the links between body fat and reproductive issues, which could lead to better diagnosis and treatment options in the future. If you’re interested, you’ll need to provide informed consent and meet the eligibility requirements.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• • Group I
• • Body mass index between 18.5 and 25.0 kg/m2.
• • Group 1 ovulatory dysfunction \[World Health Organization (WHO) classification\].
• • Normal/low gonadotrophin levels \[follicle-stimulating hormone (FSH) and luteinizing (LH) \< 10 IU/l\] and low estradiol (\< 50 pg/ml).
• • Moderate-vigorous intensity physical activity (\> 5 hours per week) plus low energy availability (\< 30 kcal/per kg of lean mass).
• • Exclusion of secondary etiologies
• • Informed consent signed.
• Group II:
• • Polycystic ovary syndrome phenotype I, II and III \[National Institute of Health (NIH)-2012\] with hyperandrogenemia (http://prevention.nih.gov/workshops/2012/resources.aspx).
• • Body mass index between 18.5 and 40.0 kg/m2.
• • Informed consent signed.
• Group III:
• • Polycystic ovary syndrome phenotype IV (NIH-2012) (http://prevention.nih.gov/workshops/2012/resources.aspx).
• • Body mass index between 18.5 and 40.0 kg/m2.
• • Informed consent signed.
• Group IV:
• • Body mass index between 18.5 and 25.0 kg/m2.
• • Regular menses.
• • Normal gonadotropins and estradiol levels at follicular phase.
• • Moderate-vigorous intensity physical activity (\> 5 hours per week) with normal energy availability (\> 30 kcal/per kg of lean mass).
• • Informed consent signed.
• Group V:
• • No signs or symptoms of hyperandrogenism.
• • No exercise or mild intensity physical activity.
• • Regular menses.
• • Body mass index between 18.5 and 40.0 kg/m2.
• • Informed consent signed.
• • Exclusion Criteria (Groups I-V)
• • Oral drugs interfering with ovulation (glucocorticoids, antipsychotics, antidepressants, contraceptives, sex steroids and/or opioids) for the previous 6 months to study inclusion.
• • Current pregnancy or lactation, or during the previous 6 months to study inclusion.
• • Asherman's syndrome or outflow tract disorders.
• • Current smoking or alcohol intake \> 40 g per day.
• • Previous diagnosis of glucose intolerance, hypertension, dyslipidemia, known heart or lung diseases, kidney disease, liver disease, celiac disease or any other malabsorptive condition, chronic inflammatory disease or malignancy.