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Fat tissue talks to the ovaries: scientists probe the hidden link

NCT ID NCT03841981

Knowledge-focused Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers want to know whether the amount, location, and behavior of body fat contribute to two hormone conditions in women: hypothalamic amenorrhea, where menstrual periods stop, and polycystic ovary syndrome (PCOS). The study enrolls 50 women across five groups, including athletes with amenorrhea, women with different types of PCOS, and healthy controls. Participants undergo body composition scans, blood tests, and metabolic measurements to look for signals from fat and muscle that might explain these conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the study identifies new signals from fat and muscle tissue, it could point to biomarkers that help diagnose or treat hypothalamic amenorrhea and PCOS.
What could go wrong
This small observational study of 50 women cannot prove cause and effect. Any biomarkers it finds would need years of further testing before they could become tests or treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

50 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with exercise-associated functional amenorrhea and polycystic ovary syndrome will be consecutively recruited from our Reproductive Endocrinolgy clinic. Those premenopausal adult women are referred to clinic because of symptoms of functional androgen excess such as hirsutism or menstrual dysfunction. The control group (Groups IV and V) will include healthy female volunteers recruited - contemporarily with the recruitment of patients - from the hospital's staff and overweight or obese women seeking medical attention in our department.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

functional hypothalamic amenorrhea Hyperandrogenism Motor Activity polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypothalamic amenorrhea Polycystic ovary syndrome

Contacts and locations

Locations

  • Endocrinology and Nutrition

    Madrid, Madrid, 28034, Spain

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