Investigating how body fat affects female reproductive health
Amount, Distribution and Dysfunction of Body Fat as Determinants of Female Gonadal Dysfunction: From Functional Hypothalamic Amenorrhea to the Polycystic Ovary Syndrome
This study is trying to see how body fat affects reproductive health in women, especially those with conditions like PCOS and exercise-related amenorrhea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT03841981 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between adipose tissue and female gonadal dysfunction, particularly in conditions like Polycystic Ovary Syndrome (PCOS) and hypothalamic amenorrhea. Researchers will analyze five groups of women, including those with exercise-related amenorrhea, various phenotypes of PCOS, and healthy controls. The study will utilize a range of assessments, including physical examinations, dietary recalls, and hormonal profiling, to identify potential signaling factors from adipose tissue that may influence reproductive health. The goal is to better understand how body fat distribution and function relate to female reproductive disorders.
Who should consider this trial
Good fit: Ideal candidates include women with specific reproductive health conditions such as hypothalamic amenorrhea or different phenotypes of PCOS.
Not a fit: Patients with a body mass index outside the specified range or those without the targeted reproductive health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of female reproductive health issues related to body fat.
How similar studies have performed: While the relationship between body fat and reproductive health has been explored, this specific approach focusing on signaling factors from adipose tissue is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid, Madrid
- Endocrinology and Nutrition — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Héctor F Escobar-Morreale, PhD, MD — Diabetes, Obesity and Human Reproduction Research Group (CIBERDEM), Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
- Study coordinator: Alejandra Quintero Tobar
- Email: mariaalejandra.quintero@salud.madrid.org
- Phone: 34913369029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.