Clinical trial NCT03043924: Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)
Official title: Functional Study of the Hypothalamus in High-resolution Magnetic Resonance Imaging (MRI) in Women With Polycystic Ovary Syndrome (PCOS): a Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: hypothalamus
Diffusion Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2017-02-06
Enrollment: 52
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change in the Apparent Diffusion Coefficient (ADC)
timeFrame: Baseline and 3 months after treatment start
Secondary outcomes:
measure: Change in the metabolite concentrations
timeFrame: Baseline and 3 months after treatment start
measure: Correlation coefficient (Spearman or Pearson) between the ADC and serum hormonal levels (FSH,luteinizing hormone,oestradiol, AMH)
timeFrame: Baseline and 3 months after treatment start
measure: Correlation coefficient (Spearman or Pearson) between the metabolite concentrations and serum hormonal levels (FSH, luteinizing hormone, oestradiol, AMH)
timeFrame: Baseline and 3 months after treatment start
measure: Plasma GnRH concentration before and after treatment (PCOS patient and control group)
timeFrame: Baseline and 3 months after treatment start
measure: Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.
timeFrame: Baseline and 3 months after treatment start
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHU
Study officials:
affiliation: University Hospital, Lille
name: Didier Dewailly, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: