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

University Hospital, Lille

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Cyproterone Acetate + estradiol; Drug: Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03043924

2016-A01391-50 (Other Identifier)

2016_22

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Female

Ages: 19 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

PCOS women

Other group

Description:

26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited.

Treatment:

Drug: Cyproterone Acetate + estradiol

Healthy volunteers

Other group

Description:

26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited.

Treatment:

Drug: Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet