Body Fat as Determinant of Female Gonadal Dysfunction

Plain-language summary

This study examines the role of body fat in female gonadal (ovarian) dysfunction, evaluating women with polycystic ovary syndrome and ovulatory disorders. Women over 18 across several groups take part through anthropometric, hormonal, and metabolic assessments. It is being conducted as a study with no assigned phase and is still recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Intervention

Anthropometric and physical examination, Indirect calorimetry, accelerometer and seven-day dietary recall, Biochemical, hormonal and metabolic phenotyping, Sonographic studies, 24-hour Ambulatory blood pressure monitoring, Percutaneous biopsy, Cardiovascular autonomic function studies, Oral smear and feces specimen

Start date

1/31/2020

Estimated completion

12/31/2025

Countries

Spain

Related genes

Locations

• Madrid, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.