Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)

University Hospital, Lille52 enrolled

Overview

The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is associated with transient microstructural and metabolic changes in the female hypothalamus using MRI approaches to assess water diffusion and measure proton magnetic resonance spectra.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

Cyproterone Acetate + estradiolDRUG

PCOS will receive: 50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily

Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral TabletDRUG

Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®)

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For all subjects * Aged from 19 to 30 years * Body mass index : 18-25 * Informed consent before inclusion * Do not smoke the 3 days before the MRI For Healthy volunteers subjects : * Regular cycles (between 25 and 35 days) AND ovulatory. * No signs of hyperandrogenism. * Subjects desirous of taking oral contraceptives (estrogen/progestin combination). * For the realization of the 2nd MRI: to be during the 3rd month of a treatment well followed by oestro-progestative monophasic minidose to 0,02mg of Ethinyl-oestradiol / 0,1mg Levonorgestrel. PCOS women: * PCOS defined by Rotterdam criteria * Needing a treatment with cyproterone acetate * To carry out the 2nd MRI: to be in progress during the 3rd month of a treatment well followed by 50 mg of Cyproterone acetate in association with 2mg / day of natural estradiol. Exclusion Criteria: * Hormone treatment within 3 months prior to inclusion (including birth control pill ) * On-going pregnancy (determined before each MRI scan visit) * Claustrophobia * Any metal or foreign implants (e.g., aneurysm clips, ear implants, heart pacemakers or defibrillators) * Diabetes or known dysthyroidism. * Current substance abuse (including smoking more than 5 cigarettes/day; determined using drug screening at the screening visit) * Pregnancy or breastfeeding the last 3 months. * Practice of intense physical exercise (ex jogging\> 10km) the day before the MRI. * Person incapable of consenting, or enjoying legal protection (guardianship / curatorship). * Unability to understand the treatment protocol

Locations (1)

Hôpital Jeanne de Flandres, CHU

Lille, France

Outcomes

Primary Outcomes

Change in the Apparent Diffusion Coefficient (ADC)

The change in the ADC will be analyzed in healthy volunteers and PCOS women before starting the oral contraceptives, and next during the third sequence of treatment.