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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Lille
• Collaborator: National Research Agency, France
• Treatments: Cyproterone; Cyproterone Acetate; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Levonorgestrel; Polyestradiol phosphate

Criteria

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