Polycystic Ovary Syndrome
Conditions
Keywords
hypothalamus, Diffusion Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy
Brief 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.
Interventions
DRUGCyproterone Acetate + estradiol
PCOS will receive: 50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily
DRUGLevonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet
Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®)
Sponsors
National Research Agency, France
University Hospital, Lille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Apparent Diffusion Coefficient (ADC) | Baseline and 3 months after treatment start | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the metabolite concentrations | Baseline and 3 months after treatment start | The change in the metabolite concentrations will be analyzed in the two groups before starting the oral contraceptives, and next during the third sequence of treatment. |
| Correlation coefficient (Spearman or Pearson) between the ADC and serum hormonal levels (FSH,luteinizing hormone,oestradiol, AMH) | Baseline and 3 months after treatment start | The correlation between ADC and hormonal levels in the two groups will be analysed before starting the contraceptive treatment and during the third processing sequence. |
| Correlation coefficient (Spearman or Pearson) between the metabolite concentrations and serum hormonal levels (FSH, luteinizing hormone, oestradiol, AMH) | Baseline and 3 months after treatment start | The correlation between metabolite concentrations and hormonal levels in the two groups will be analysed before starting the contraceptive treatment and during the third processing sequence. |
| Plasma GnRH concentration before and after treatment (PCOS patient and control group) | Baseline and 3 months after treatment start | — |
| Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception. | Baseline and 3 months after treatment start | — |
Countries
France
Outcome results
None listed