Status:
RECRUITING
Body Fat as Determinant of Female Gonadal Dysfunction
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborating Sponsors:
Instituto de Salud Carlos III
University of Alcala
Conditions:
Polycystic Ovary Syndrome
Hypothalamic Amenorrhea
Eligibility:
FEMALE
18-40 years
Brief Summary
Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03841981
Start Date
January 31 2020
End Date
December 31 2025
Last Update
August 12 2025
Active Locations (1)
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1
Endocrinology and Nutrition
Madrid, Madrid, Spain, 28034