Actively Recruiting

Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID03841981

Amount, Distribution and Dysfunction of Body Fat as Determinants of Female Gonadal Dysfunction From Functional Hypothalamic Amenorrhea to Polycystic Ovary Syndrome

Led by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Updated on 2025-08-12

50

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

F

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Lead Sponsor

I

Instituto de Salud Carlos III

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates how abnormalities in body fat amount, distribution, and function relate to female gonadal dysfunctions, including hypothalamic amenorrhea and polycystic ovary syndrome (PCOS). The study aims to better understand how fat tissue communicates with the female reproductive system and to identify new biomarkers that could help diagnose and treat these conditions. Participants include women with different types of PCOS, exercise-related amenorrhea, and healthy controls. Women in five groups will be studied, including those with exercise-associated hypothalamic amenorrhea, hyperandrogenic and non-hyperandrogenic PCOS (both lean and with weight excess), women who exercise but have normal ovulation, and healthy women with no regular exercise. Researchers will collect samples and data from fat tissue, muscle, blood, and microbiome to analyze proteins, gene expression, hormones, body composition, cardiovascular health, and inflammatory markers. Participants will undergo detailed physical exams, body composition scans, blood tests, glucose tolerance tests, ultrasound imaging, blood pressure monitoring, biopsies, and microbiome sampling. Researchers will measure adipokine and myokine signals over up to five years and assess their associations with reproductive hormones and cardiovascular risk factors. The study includes comprehensive monitoring of metabolism, inflammation, oxidative stress, and the microbiome to explore their links to reproductive health.

CONDITIONS

Brief Title

Body Fat as Determinant of Female Gonadal Dysfunction

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 40 years
  • Signed informed consent
  • For Group I: BMI between 18.5 and 25.0 kg/m2, ovulatory dysfunction per WHO, low gonadotropins and estradiol, moderate-vigorous exercise >5 hours/week with low energy availability
  • For Group II: NIH-2012 PCOS phenotypes I-III with hyperandrogenemia, BMI 18.5 to 40.0 kg/m2
  • For Group III: NIH-2012 PCOS phenotype IV, BMI 18.5 to 40.0 kg/m2
  • For Group IV: BMI 18.5 to 25.0 kg/m2, regular menses, normal hormones, moderate-vigorous exercise >5 hours/week with normal energy availability
  • For Group V: No hyperandrogenism signs, no or mild exercise, regular menses, BMI 18.5 to 40.0 kg/m2
Not Eligible

You will not qualify if you...

  • Use of oral drugs affecting ovulation (glucocorticoids, antipsychotics, antidepressants, contraceptives, sex steroids, opioids) within past 6 months
  • Current pregnancy or lactation, or within past 6 months
  • Asherman's syndrome or outflow tract disorders
  • Current smoking or alcohol intake exceeding 40 g/day
  • Previous diagnosis of glucose intolerance, hypertension, dyslipidemia, heart or lung disease, kidney or liver disease, celiac disease or malabsorption, chronic inflammatory disease, or cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Diagnostic Evaluation

Duration - Up to 5 years

Participants undergo various diagnostic assessments including anthropometric and physical examinations, biochemical and hormonal phenotyping, sonographic studies, cardiovascular autonomic function studies, microbiome specimen collection, energy availability assessments, 24-hour ambulatory blood pressure monitoring, and tissue biopsies to study body fat distribution and female gonadal dysfunction.

Initial comprehensive assessment visit with possible follow-up assessments depending on cohort assignment

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored over time to investigate associations between body composition, sex steroids, metabolic parameters, cardiovascular function, and other health markers related to female gonadal dysfunction.

Periodic follow-up visits as determined by study protocol

Trial Site Locations

Total: 1 location

1

Endocrinology and Nutrition

Madrid, Madrid, Spain, 28034

Actively Recruiting

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Research Team

A

Alejandra Quintero Tobar

S

Sara de Lope Quiñones

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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