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

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Cyproterone Acetate + estradiol; Drug: Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet

• Registration Number: NCT03043924
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Study Start: 2017-09-26
• Status Verified: 2022-04
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCOS women	Cyproterone Acetate + estradiol	26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited.
Healthy volunteers	Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet	26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Plasma GnRH concentration before and after treatment (PCOS patient and control group)	Baseline and 3 months after treatment start
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.
Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.	Baseline and 3 months after treatment start

Trial Locations

Locations (1)

Hôpital Jeanne de Flandres, CHU; 🇫🇷 Lille, France